BIOTRONIK SE and KG LUMAXT50 UserMan

Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

 VR ICD
 VR-T ICD
 VR-T DX ICD
 DR ICD
 DR-T ICD
 HF CRT-D
 HF-T CRT-D

Technical Manual

X-ray Identification
Lumax Family

Implantable Cardioverter Defibrillator and Cardiac
Resynchronization Therapy Defibrillators
Inside the housing:

Belos Technical Manual iii

Model X-Ray Identification Year of Manufacture

Lumax 300 HR nn

Lumax 340 HR nn

Lumax 500 SH nn

Lumax 540 SH nn

Lumax 600 RH nn

Lumax 640 RH nn

Lumax 700 RH nn

Lumax 740 RH nn

CAUTION

Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.

2011 BIOTRONIK, Inc., all rights reserved.

Lumax Technical Manual i

Contents

1. General ..............................................................................1

1.1 System Description .......................................................1

1.2 Indications and Usage...................................................4

1.3 Contraindications...........................................................5

1.4 Warnings and Precautions ............................................5

1.4.1 Sterilization, Storage, and Handling ......................8

1.4.2 Device Implantation and Programming .................8

1.4.3 Lead Evaluation and Connection ........................10

1.4.4 Follow-up Testing ................................................12

1.4.5 Pulse Generator Explant and Disposal ...............12

1.4.6 Hospital and Medical Hazards.............................12

1.4.7 Home and Occupational Hazards .......................14

1.4.8 Cellular Phones ...................................................14

1.4.9 Electronic Article Surveillance (EAS) ..................15

1.4.10 Home Appliances ................................................15

1.4.11 Home Monitoring® ..............................................15

1.5 Potential/Observed Effects of the Device on Health ...17

1.5.1 Potential Adverse Events ....................................17

1.5.2 Observed Adverse Events...................................18

1.6 Clinical Studies............................................................27

1.6.1 Kronos LV-T Study ..............................................28

1.6.2 Tupos LV/ATx Study............................................30

1.6.3 Lumax HF-T V-V Clinical Study...........................48

1.6.4 TRUST Clinical Study..........................................55

1.6.5 Deikos A+ ............................................................63

1.7 Patient Selection and Treatment.................................67

1.7.1 Individualization of Treatment .............................67

1.7.2 Specific Patient Populations................................68

1.8 Patient Counseling Information ...................................68

1.9 Evaluating Prospective CRT-D/ICD Patients ..............69

2. Device Features ..............................................................70

2.1 SafeSync Telemetry ....................................................70

2.2 Cardiac Resynchronization Therapy (CRT) ................73

2.3 Sensing (Automatic Sensitivity Control) ......................76

2.3.1 Right Ventricular Sensitivity Settings...................77

2.3.2 Minimum Right Ventricular Threshold .................79

ii Lumax Technical Manual

2.3.3 Atrial Sensitivity Settings .....................................79

2.3.4 Minimum Atrial Threshold....................................80

2.3.5 Left Ventricular Sensitivity Settings .....................80

2.3.6 Minimum Left Ventricular Threshold....................81

2.3.7 Far Field Protection .............................................81

2.3.8 Additional Sensing Parameters ...........................81

2.4 Automatic Threshold Measurement (ATM) .................83

2.4.1 Signal Quality Check ...........................................84

2.4.2 Threshold Measurement .....................................84

2.4.3 Loss of Capture Detection...................................84

2.4.4 ATM in Lumax HF-T Models ...............................84

2.4.5 RV & LV Capture Control ....................................85

2.5 Ventricular Tachyarrhythmia Detection........................85

2.5.1 VF Classifications ................................................86

2.5.2 VT Interval Counters............................................86

2.5.3 VT Classification..................................................86

2.5.4 SMART Detection™ ............................................87

2.5.5 Onset ...................................................................88

2.5.6 Stability ................................................................88

2.5.7 Sustained VT Timer.............................................88

2.5.8 VT Monitoring Zone .............................................89

2.5.9 Atrial Monitoring Zone .........................................89

2.6 Tachyarrhythmia Redetection......................................90

2.6.1 VT Redetection....................................................90

2.6.2 SMART Redetection............................................90

2.6.3 Forced Termination .............................................90

2.6.4 VF Redetection....................................................91

2.7 Tachyarrhythmia Termination ......................................91

2.8 Tachyarrhythmia Therapy ............................................91

2.8.1 Therapy Options ..................................................91

2.8.2 Anti-Tachycardia Pacing (ATP) ...........................91

2.8.3 Shock Therapy ....................................................95

2.8.4 Progressive Course of Therapy.........................101

2.9 Bradycardia Therapy .................................................102

2.9.1 Bradycardia Pacing Modes ...............................102

2.9.2 Basic Rate .........................................................103

2.9.3 Night Rate..........................................................103

2.9.4 Rate Hysteresis .................................................104

2.9.5 Dynamic AV Delay.............................................107

2.9.6 IOPT ..................................................................110

Lumax Technical Manual iii

2.9.7 Upper Tracking Rate .........................................110

2.9.8 Mode Switching .................................................111

2.9.9 PMT Management .............................................113

2.9.10 VES Discrimination after Atrial Sensed Events .115

2.9.11 Rate-Adaptive Pacing........................................116

2.9.12 Pulse Amplitude.................................................118

2.9.13 Pulse Width .......................................................118

2.9.14 Post Ventricular Atrial Refractory Period...........118

2.9.15 PVARP after VES ..............................................118

2.9.16 Auto PVARP ......................................................119

2.9.17 Noise Response ................................................119

2.9.18 Post Shock Pacing ............................................119

2.10 EP Test Functions......................................................120

2.10.1 P and R-wave Amplitude Measurements ..........120

2.10.2 Pacing Impedance Measurements....................121

2.10.3 Shock Impedance Measurements.....................121

2.10.4 Testing for Retrograde Conduction ...................122

2.10.5 Pacing Threshold...............................................122

2.10.6 Arrhythmia Induction Features ..........................123

2.10.7 Manual Shock ....................................................124

2.10.8 Test Shock.........................................................124

2.10.9 Manual ATP .......................................................125

2.10.10 Emergency Shock .............................................125

2.11 Special Features........................................................125

2.11.1 ICD Therapy Status ...........................................125

2.11.2 Thoracic Impedance ..........................................126

2.11.3 Home Monitoring®.............................................126

2.11.4 Real-time IEGM Transmission ..........................138

2.11.5 Capacitor Reforming .........................................139

2.11.6 Patient and Implant Data ...................................140

2.11.7 System Status ...................................................140

2.11.8 HF Monitor Statistics .........................................141

2.11.9 Holter Memory ...................................................142

2.11.10 Timing Statistics ................................................144

2.11.11 Atrial Arrhythmias ..............................................145

2.11.12 Ventricular Arrhythmias .....................................145

2.11.13 Sensor ...............................................................146

2.11.14 Sensing..............................................................146

2.11.15 Impedances.......................................................146

2.11.16 Automatic Threshold..........................................146

2.11.17 Asynchronous Pacing Modes............................146

iv Lumax Technical Manual

2.11.18 Far-Field IEGM for Threshold Testing (Leadless

ECG)..................................................................147

2.11.19 Advanced AT/AF Diagnostics (Lumax 700/740 only)

...........................................................................147

2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only) ...148

3. Sterilization and Storage .............................................149

4. Implant Procedure ........................................................151

4.1 Implant Preparation ...................................................151

4.2 Lead System Evaluation............................................156

4.3 Opening the Sterile Container...................................156

4.4 Pocket Preparation....................................................157

4.5 Lead to Device Connection .......................................158

4.6 Blind Plug Connection...............................................161

4.7 Program the ICD/CRT-D ...........................................162

4.8 Implant the ICD/CRT-D .............................................163

5. Follow-up Procedures..................................................167

5.1 General Considerations ............................................167

5.2 Longevity ...................................................................168

5.2.1 Lumax 300/340 Devices....................................169

5.2.2 Lumax 500/540 Devices....................................171

5.2.3 Lumax 600/640 & 700/740 Devices ..................174

5.3 Explantation...............................................................176

6. Technical Specifications..............................................179

Appendix A ..........................................................................198

Appendix B – Known Anomalies.......................................200

Lumax Technical Manual v

Figure 1. Lumax 300/340 ICDs and CRT-D

VR(-T) DR(-T)/VR-T DX HF(-T)

Figure 2. Lumax 500/540, 600/640 & 700/740 ICDs and CRT-D

Table 1. Lumax Specifications

Battery Voltage 3.2 Volts
Maximum Shock Energy

300/500/600/700 Models 30 Joules programmed

340/540/640/740 Models 40 Joules programmed
Defibrillation Lead Ports Two DF1 (3.2 mm)
Pacing Lead Ports

vi Lumax Technical Manual

VR(-T) Models One IS-1 (3.2 mm)

DR(-T)/VR-T DX Models Two IS-1 (3.2 mm)

HF(-T) Models Three IS-1 (3.2 mm)
Materials

Housing Titanium

Header Epoxy Resin

Sealing Plug Silicone

Detailed technical specifications are provided in Section

6.

Lumax Technical Manual 1

1. General

1.1 System Description

The Lumax family of Implantable Cardioverter Defibrillators
(ICDs) and Cardiac Resynchronization Therapy Defibrillators
(CRT-Ds) detect and treat ventricular tachyarrhythmias and
provide rate adaptive bradycardia pacing support. The HF and
HF-T versions of Lumax provide Cardiac Resynchronization
Therapy (CRT) through biventricular pacing. Both CRT-Ds and
ICDs detect and treat ventricular tachyarrhythmias and provide
rate adaptive bradycardia pacing support. They are designed to
collect diagnostic data to aid the physician’s assessment of a
patient’s condition and the performance of the implanted device.

The Lumax family of devices provides therapy for ventricular
tachyarrhythmias with a sophisticated range of programmable
anti-tachycardia pacing (ATP), and/or defibrillation therapy
features. The shock polarity and energy may be programmed to
tailor the therapy to appropriately treat each patient's
tachyarrhythmias. The ICDs/CRT-Ds provide shock therapies
with programmable energies from 5 to 40 joules.

The Lumax family of ICDs/CRT-Ds includes the following
members:

 Lumax HF - provides three chamber rate-adaptive

bradycardia pacing support including biventricular pacing
via a left ventricular pacing lead. The CRT-D uses right
atrial and ventricular sensing/pacing leads to provide
enhanced atrial and ventricular tachyarrhythmia
discrimination through BIOTRONIK’s SMART Detection™
algorithm.

 Lumax HF-T - In addition, to the functionality found with

HF model, Lumax HF-T also has BIOTRONIK’s Home
Monitoring system. The Home Monitoring System
enables automatic exchange of information about a
patient’s cardiac status from the implant to the physician
remotely.

 Lumax DR - provides dual chamber rate adaptive

bradycardia pacing support. The ICD uses atrial and
ventricular sensing/pacing leads to provide enhanced
atrial and ventricular tachyarrhythmia discrimination
through BIOTRONIK’s SMART Detection

TM

algorithm.

2 Lumax Technical Manual

 Lumax DR-T - In addition, to the functionality found with

the DR model, it also has BIOTRONIK’s Home
Monitoring® system. The Home Monitoring System
enables automatic exchange of information about a
patient’s cardiac status from the implant to the physician
remotely.

 Lumax VR - provides single chamber rate adaptive

bradycardia pacing support as well as tachyarrhythmia
detection and therapy.

 Lumax VR-T - In addition, to the functionality found with

standard VR model, it also has BIOTRONIK’s Home
Monitoring system. The Home Monitoring System
enables automatic exchange of information about a
patient’s cardiac status from the implant to the physician
remotely.

 Lumax VR-T DX – provides ventricular rate adaptive

bradycardia pacing support that can include atrial
tracking with a single pass ICD lead and also has
BIOTRONIK’s Home Monitoring system.

The 300/500/600/700 and 340/540/640/740 designation for each
of the above-described models denote the maximum
programmable shock energy of 30 joules and 40 joules,
respectively.

The Lumax 500/540, 600/640 and 700/740 models feature a third
programmable shock path for delivery of
defibrillation/cardioversion shocks. The shock path is
programmable between the different shock coils (SVC/RV) and/or
the device housing. Section

2.8.3.6 provides further details on

the available shock configurations. The Lumax 600/640 and
700/740 models also feature an additional left ventricular (LV)
pacing polarity for HF-T devices from LV-tip to housing (unipolar).

Additionally, the Lumax 500/540 models feature Automatic
Threshold Measurement (ATM) of ventricular pacing thresholds.
This feature is separately programmable for the right (RV) and left
(LV) ventricle. Section 2.4 provides further details.

Lumax Technical Manual 3

The Lumax 700/740 and 600/640 models feature ATM with
automatic adjustment of pacing amplitudes (RV & LV Capture
Control). This feature functions the same as ATM for threshold
search and is also separately programmable for the right (RV)
and left (LV) ventricle. In addition, it automatically adjusts the
permanent pacing amplitude with a programmed safety margin.
Section 2.4.5 provides a detailed description of this feature.

The Lumax 600/640 and 700/740 also provides wandless
telemetry

to ease implantation and follow-up procedures. In
addition, these devices include Thoracic Impedance monitoring
and Atrial NIPS that can be used for an EP study to induce an
arrhythmia or to burst pace a patient out of a stable
tachyarrhythmia.

Lumax 700/740 and 600/640 will present with automatic Far-Field
IEGM to provide a means to generate the surface ECG-like signal
without the need for attaching the surface electrodes to the
patients.

The Lumax HF (-T) models have three IS-1 pacing/sensing
header ports and two DF-1 defibrillation/cardioversion ports. The
Lumax DR (-T) models have two IS-1 pacing/sensing header
ports. The Lumax VR (-T) models have one IS-1 pacing/sensing
header ports. IS-1 refers to the international standard whereby
leads and generators from different manufacturers are assured a
basic fit [Reference ISO 5841-3:1992]. DF-1 refers to the
international standard for defibrillation lead connectors
[Reference ISO 11318:1993].

External devices that interact with and test the implantable
devices are also part of the ICD/CRT-D System. These external
devices include the Programming and Tachyarrhythmia
Monitoring System and the Implant Module System Analyzer or
Pacing System Analyzer for acute lead testing. The ICS 3000 or
Renamic programmer are used to interrogate and program the
ICD/CRT-Ds.

The Lumax 600/640 and 700/740 models also feature SafeSync
Telemetry (RF-Telemetry) via the Renamic programmer or the
ICS 3000 programmer in combination with the SafeSync Module
(an external communication module).

4 Lumax Technical Manual

BIOTRONIK conducted the TRUST study to evaluate the safety
and effectiveness of Home Monitoring, which is available in most
models of this device. Refer to Section 1.6.4 for details regarding
the study design and
BIOTRONIK was able to show the following with regards to Home
Monitoring:

 BIOTRONIK Home Monitoring information may be used as a

replacement for device interrogation during in-office follow-up
visits.

 A strategy of care using BIOTRONIK Home Monitoring with

office visits when needed has been shown to extend the time
between routine, scheduled in-office follow-ups of
BIOTRONIK implantable devices in many patients. Home
Monitoring data is helpful in determining the need for
additional in-office follow-up.

 BIOTRONIK Home Monitoring-patients—who are followed

remotely with office visits when needed—have been shown to
have similar numbers of strokes, invasive procedures and
deaths as patients followed with conventional in-office
follow-ups.

 BIOTRONIK Home Monitoring provides early detection of

arrhythmias.

 BIOTRONIK Home Monitoring provides early detection of

silent, asymptomatic arrhythmias.

 Automatic early detection of arrhythmias and device system

anomalies by BIOTRONIK Home Monitoring allows for earlier
intervention than conventional in-office follow-ups.

 BIOTRONIK Home Monitoring allows for improved access to

patient device data compared to conventional in-office
follow-ups since device interrogation is automatically
scheduled at regular intervals.

results. With the TRUST study,

1.2 Indications and Usage

The Lumax CRT-Ds are indicated for use in patients with all of the
following conditions:

 Indicated for ICD therapy
 Receiving optimized and stable Congestive Heart Failure

(CHF) drug therapy

 Symptomatic CHF (NYHA Class III/IV and LVEF  35%);

and

Lumax Technical Manual 5

 Intraventricular conduction delay (QRS duration 130 ms)

The Lumax Implantable Cardioverter Defibrillators (ICDs) and
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are
intended to provide ventricular anti-tachycardia pacing and
ventricular defibrillation, for automated treatment of life­threatening ventricular arrhythmias.

1.3 Contraindications

The Lumax devices are contraindicated for use in patients with
the following conditions:

 Patients whose ventricular tachyarrhythmias may have

transient or reversible causes such as:

 Acute myocardial infarction
 Digitalis intoxication
 Drowning
 Electrocution
 Electrolyte imbalance
 Hypoxia
 Sepsis
 Patients with incessant ventricular fibrillation (VF) and

ventricular tachycardia (VT)

 Patients whose only disorder is brady arrhythmias or

atrial arrhythmias

1.4 Warnings and Precautions

MRI (Magnetic Resonance Imaging) - Do not expose a patient

to MRI device scanning. Strong magnetic fields may damage the
device and cause injury to the patient.

Electrical Isolation - To prevent inadvertent arrhythmia
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.

Left Ventricular Lead Systems – BIOTRONIK CRT-Ds may be
implanted with any legally marketed, compatible LV lead.
Compatibility is defined as:

 IS-1 pacing connector
 Active or passive fixation technology
 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1)

6 Lumax Technical Manual

The following LV leads were evaluated in the OPTION CRT/ATx
study with BIOTRONIK’s CRT-Ds:

 Guidant-EASYTRAK® IS-1 Lead
 Guidant-EASYTRAK LV-1 Lead
 Guidant-EASYTRAK 2 Lead
 Guidant-EASYTRAK 3 Lead
 Medtronic-Attain® OTW Lead
 St. Jude-Aescula
 St. Jude-QuickSite® Lead
 Biomec-Myopore

TM

Lead

TM

Epicardial Lead

 Medtronic-Epicardial 5071 Lead
 Medtronic-CapSure® EPI Lead
 BIOTRONIK-ELC 54-UP Lead

The following LV leads were bench tested for compatibility with
BIOTRONIK’s CRT-Ds:

 Guidant EASYTRAK 4512 (unipolar) Lead
 Guidant EASYTRAK 4513 (bipolar) Lead
 Guidant EASYTRAK 3 4525 (bipolar) Lead
 Medtronic Attain OTW 4193 (unipolar) Lead
 Medtronic Attain OTW 4194 (bipolar) Lead
 Medtronic Attain LV 2187 (unipolar) Lead
 St. Jude Medical QuickSite 1056K (unipolar) Lead
 ELA SITUS® OTW (unipolar) Lead
 BIOTRONIK Corox OTW 75-UP Steroid #346542

(unipolar) Lead

 BIOTRONIK Corox+ LV-H 75-BP #341885 (bipolar) Lead

ICD Lead Systems – BIOTRONIK ICDs/CRT-Ds maybe
implanted with any legally marketed, compatible ICD lead.
Compatibility is defined as:

 IS-1 pacing and sensing connector(s)
 DF-1 shock coil connector(s)
 Integrated or dedicated bipolar pacing and sensing

configuration

 Active or passive fixation technology
 Single or dual defibrillation shock coil (s)
 High energy shock accommodation of at least 30 joules

Lumax Technical Manual 7

 Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

The following leads were evaluated in a retrospective study with
BIOTRONIK’s ICDs/CRT-Ds:

 Medtronic Sprint
 Medtronic Sprint Lead 6943
 Medtronic Sprint Quattro
 Medtronic Transvene
 St. Jude (Ventritex) TVL

TM

Lead 6932

TM

TM

RV Lead 6936

TM

Lead 6944

- ADX Lead 1559

 St. Jude SPL® SP02 Lead
 Guidant ENDOTAK® DSP Lead
 Guidant ENDOTAK Endurance EZ Lead, ENDOTAK

Reliance Lead

 Guidant (Intermedics) Lead 497-24.

The following leads were bench tested for compatibility with
BIOTRONIK’s ICDs/CRT-Ds:

 Guidant ENDOTAK Endurance Lead “CPI 0125”
 Guidant ENDOTAK Reliance Lead 0148
 Medtronic Sprint Lead 6932
 Medtronic Sprint Lead 6942
 Medtronic Sprint Lead 6943
 Medtronic Sprint Lead6945
 Medtronic Sprint Quattro Lead 6944
 St. Jude Riata® Lead 1571/65
 St. Jude SPL SPO1 Lead.

Resuscitation Availability - Do not perform induction testing
unless an alternate source of patient defibrillation such as an
external defibrillator is readily available. In order to implant the
ICD/CRT-D system, it is necessary to induce and convert the
patient’s ventricular tachyarrhythmias.

Unwanted Shocks – Always program ICD Therapy to OFF prior
to handling the device to prevent the delivery of serious shocks to
the patient or the person handling the device during the implant
procedure.

Rate-Adaptive Pacing – Use rate-adaptive pacing with care in
patients unable to tolerate increased pacing rates.

8 Lumax Technical Manual

1.4.1 Sterilization, Storage, and Handling

Device Packaging - Do not use the device if the device’s

packaging is wet, punctured, opened or damaged because the
integrity of the sterile packaging may be compromised. Return the
device to BIOTRONIK.

Re-sterilization - Do not re-sterilize and re-implant explanted
devices.

Storage (temperature) - Store the device between 5° to 45°C
(41° - 113° F) because temperatures outside this range could
damage the device.

Storage (magnets) - To avoid damage to the device, store the
device in a clean area, away from magnets, kits containing
magnets, and sources of electromagnetic interference (EMI).

Temperature Stabilization - Allow the device to reach room
temperature before programming or implanting the device
because temperature extremes may affect initial device function.

Use Before Date - Do not implant the device after the USE
BEFORE DATE because the device may have reduced longevity.

1.4.2 Device Implantation and Programming

Blind Plug - A blind plug must be inserted and firmly connected

into any unused header port to prevent chronic fluid influx and
possible shunting of high energy therapy.

Capacitor Reformation - Infrequent charging of the high voltage
capacitors may extend the charge times of the ICD/CRT-D. The
capacitors are reformed automatically at least every 90 days. For
further information, please refer to Section
Reforming.

Connector Compatibility – ICD/CRT-D and lead system
compatibility should be confirmed prior to the implant procedure.
Consult your BIOTRONIK representative regarding lead/pulse
generator compatibility prior to the implantation of an ICD/CRT-D
system. For further information, please refer to Appendix A

2.11.5, Capacitor

.

Lumax Technical Manual 9

ERI (Elective Replacement Indicator) - Upon reaching ERI, the
battery has sufficient energy remaining to continue monitoring for
at least three months and to deliver a minimum of six maximum
energy shocks. After this period (EOS), all tachyarrhythmia
detection and therapy is disabled. Bradycardia functions are still
active at programmed values until the battery voltage drops below

1.75 volts.

Magnets - Positioning of a magnet or the programming wand
over the ICD/CRT-D will suspend tachycardia detection and
treatment. The minimum magnet strength required to suspend
tachycardia treatment is 1.8 mT. When the magnet strength
decreases to less than 1 mT, the reed contact is reopened.

Programmed Parameters – Program the device parameters to
appropriate values based on the patient’s specific arrhythmias
and condition.

Programmers - Use only BIOTRONIK ICS 3000 or Renamic
programmers to communicate with the device.

Sealing System - Failure to properly insert the torque wrench
into the perforation at an angle perpendicular to the connector
receptacle may result in damage to the sealing system and its
self-sealing properties.

Defibrillation Threshold - Be aware that changes in the patient’s
condition, drug regimen, and other factors may change the
defibrillation threshold (DFT) which may result in non-conversion
of the arrhythmia post-operatively. Successful conversion of
ventricular fibrillation or ventricular tachycardia during arrhythmia
conversion testing is no assurance that conversion will occur
post-operatively.

Manual Shocks – User-commanded shocks may be withheld if
the ICD/CRT-D is already busy processing a manual command or
the Battery Status is low.

Charge Time - When preparing a high energy shock the charge
circuit stops charging the capacitors after 20 seconds, and
delivers the stored energy as shock therapy. After the device
reaches ERI the stored energy may be less than the maximum
programmable energy for each shock.

10 Lumax Technical Manual

Programming Wand Separation Distance – The wand (with
magnet) must not be placed closer than 2 cm to the device
(implanted or out of the box). Programming wand (with magnet)
distance closer than 2 cm may damage the device.

Shipment Mode – The shipment mode is a factory set mode that
controls the charge current of automatic capacitor reformations.
This mode controls the charge current to avoid temporary low
battery readings. The shipment mode is automatically deactivated
as soon as electrophysiological tests (e.g., Impedance
measurement) have been performed. To ensure delivery of
programmed shock energy, make sure shipment mode is
disabled prior to completion of implant procedure.

Shock Therapy Confirmation – Programming CONFIRMATION
to OFF may increase the incidence of the ICD/CRT-D delivering
inappropriate shocks.

Shock Impedance - If the shock impedance is less than twenty­five ohms (25 Ω), reposition the lead system to allow a greater
distance between the electrodes. Never implant the device with a
lead system that has measured shock impedance of less than
twenty-five ohms (25 Ω). Damage to the device may result.

Negative AV Hysteresis – This feature insures ventricular
pacing, a technique which has been used in patients with
hypertrophic obstructive cardiomyopathy (HOCM) with normal AV
conduction in order to replace intrinsic ventricular activation. No
clinical study was conducted to evaluate this feature, and there is
conflicting evidence regarding the potential benefit of ventricular
pacing therapy for HOCM patients. In addition, there is evidence
with other patient groups to suggest that inhibiting the intrinsic
ventricular activation sequence by right ventricular pacing may
impair hemodynamic function and/or survival.

1.4.3 Lead Evaluation and Connection

Capping Leads - If a lead is abandoned rather than removed, it

must be capped to ensure that it is not a pathway for currents to
or from the heart.

Gripping Leads - Do not grip the lead with surgical instruments
or use excessive force or surgical instruments to insert a stylet
into a lead.

Lumax Technical Manual 11

Kinking Leads - Do not kink leads. This may cause additional
stress on the leads that can result in damage to the lead.

Liquid Immersion - Do not immerse leads in mineral oil, silicone
oil, or any other liquid.

Short Circuit - Ensure that none of the lead electrodes are in
contact (a short circuit) during delivery of shock therapy as this
may cause current to bypass the heart or cause damage to the
ICD/CRT-D system.

Far-Field Sensing of signals from the atrium in the ventricular
channel or ventricular signals in the atrial channel should be
avoided by appropriate lead placement, programming of
pacing/sensing parameters, and maximum sensitivity settings. If it
is necessary to modify the Far Field Blanking parameter, the
parameter should be lengthened only long enough to eliminate
far-field sensing as evidenced on the IEGMs. Extending the
parameter unnecessarily may cause under sensing of actual atrial
or ventricular events.

Suturing Leads - Do not suture directly over the lead body as
this may cause structural damage. Use the appropriate suture
sleeve to immobilize the lead and protect it against damage from
ligatures.

Tricuspid Valve Bioprosthesis - Use ventricular transvenous
leads with caution in patients with a tricuspid valvular
bioprosthesis.

Setscrew Adjustment – Back-off the setscrew(s) prior to
insertion of lead connector(s) as failure to do so may result in
damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s) – To prevent cross threading the
setscrew(s), do not back the setscrew(s) completely out of the
threaded hole. Leave the torque wrench in the slot of the
setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not over tighten the setscrew(s).
Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque wrench
into the perforation perpendicular to the connector receptacle.
Failure to do so may result in damage to the plug and its self­sealing properties.

12 Lumax Technical Manual

1.4.4 Follow-up Testing

Defibrillation Threshold - Be aware that changes in the patient’s

condition, drug regimen, and other factors may change the
defibrillation threshold (DFT), which may result in non-conversion
of the arrhythmia post-operatively. Successful conversion of
ventricular fibrillation or ventricular tachycardia during arrhythmia
conversion testing is no assurance that conversion will occur
post-operatively.

Resuscitation Availability - Ensure that an external defibrillator
and medical personnel skilled in cardiopulmonary resuscitation
(CPR) are present during post-implant device testing should the
patient require external rescue.

Safe Program – Within the EP Test screen, pressing the “Safe
Program” key on the programmer head immediately sends the
safe program to the ICD/CRT-D.

1.4.5 Pulse Generator Explant and Disposal

Device Incineration – Never incinerate the ICD/CRT-D due to

the potential for explosion. The ICD/CRT-D must be explanted
prior to cremation.

Explanted Devices – Return all explanted devices to
BIOTRONIK.

Unwanted Shocks – Always program ICD Therapy to OFF prior
to handling the device to prevent the delivery of serious shocks to
the patient or the person handling the device during the
procedure.

1.4.6 Hospital and Medical Hazards

Electromagnetic interference (EMI) signals present in hospital
and medical environments may affect the function of any
ICD/CRT-D or pacemaker. The ICD/CRT-D is designed to
selectively filter out EMI noise. However, due to the variety of EMI
signals, absolute protection from EMI is not possible with this or
any other ICD/CRT-D.

The ICD/CRT-D system should have detection and therapy
disabled (OFF) prior to performing any of the following medical
procedures. In addition, the ICD/CRT-D should be checked after
the procedures to assure proper programming:

Lumax Technical Manual 13

Diathermy - Diathermy therapy is not recommended for
ICD/CRT-D patients due to possible heating effects of the pulse
generator and at the implant site. If diathermy therapy must be
used, it should not be applied in the immediate vicinity of the
pulse generator or lead system.

Electrocautery - Electrosurgical cautery could induce ventricular
arrhythmias and/or fibrillation, or may cause device malfunction or
damage. If use of electrocautery is necessary, the current path
and ground plate should be kept as far away from the pulse
generator and leads as possible (at least 6 inches (15 cm)).

External Defibrillation - The device is protected against energy
normally encountered from external defibrillation. However, any
implanted device may be damaged by external defibrillation
procedures. In addition, external defibrillation may also result in
permanent myocardial damage at the electrode-tissue interface as
well as temporary or permanent elevated pacing thresholds. When
possible, observe the following precautions:

 Position the adhesive electrodes or defibrillation paddles

of the external defibrillator anterior-posterior or along a
line perpendicular to the axis formed by the implanted
device and the heart.

 Set the energy to a level not higher than is required to

achieve defibrillation.

 Place the paddles as far as possible away from the

implanted device and lead system.

 After delivery of an external defibrillation shock,

interrogate the ICD/CRT-D to confirm device status and
proper function.

Lithotripsy - Lithotripsy may damage the ICD/CRT-D. If
lithotripsy must be used, avoid focusing near the ICD/CRT-D
implant site.

MRI (Magnetic Resonance Imaging) - Do not expose a patient
to MRI device scanning. Strong magnetic fields may damage the
device and cause injury to the patient.

Radiation - High radiation sources such as cobalt 60 or gamma
radiation should not be directed at the pulse generator. If a patient
requires radiation therapy in the vicinity of the pulse generator,
place lead shielding over the device to prevent radiation damage
and confirm its function after treatment.

14 Lumax Technical Manual

Radio Frequency Ablation - Prior to performing an ablation
procedure, deactivate the ICD/CRT-D during the procedure.
Avoid applying ablation energy near the implanted lead system
whenever possible.

1.4.7 Home and Occupational Hazards

Patients should be directed to avoid devices that generate strong
electromagnetic interference (EMI) or magnetic fields. EMI could
cause device malfunction or damage resulting in non-detection or
delivery of unneeded therapy. Moving away from the source or
turning it off will usually allow the ICD/CRT-D to return to its
normal mode of operation.

The following equipment (and similar devices) may affect normal
ICD/CRT-D operation: electric arc or resistance welders, electric
melting furnaces, radio/television and radar transmitters,
power-generating facilities, high-voltage transmission lines, and
electrical ignition systems (of gasoline-powered devices) if
protective hoods, shrouds, etc., are removed.

1.4.8 Cellular Phones

Testing has indicated there may be a potential interaction
between cellular phones and BIOTRONIK ICD/CRT-D systems.
Potential effects may be due to either the cellular phone signal or
the magnet within the telephone and may include inhibition of
therapy when the telephone is within 6 inches (15 centimeters) of
the ICD/CRT-D, when the ICD/CRT-D is programmed to standard
sensitivity.

Patients having an implanted BIOTRONIK ICD/CRT-D who
operate a cellular telephone should:

 Maintain a minimum separation of 6 inches

(15 centimeters) between a hand-held personal cellular
telephone and the implanted device.

 Set the telephone to the lowest available power setting, if

possible.

Lumax Technical Manual 15

 Patients should hold the phone to the ear opposite the

side of the implanted device. Patients should not carry
the telephone in a breast pocket or on a belt over or
within 6 inches (15 centimeters) of the implanted device
as some telephones emit signals when they are turned
ON, but not in use (i.e., in the listen or stand-by mode).
Store the telephone in a location opposite the side of

Based on results to date, adverse effects resulting from
interactions between cellular telephones and implanted
ICDs/CRT-Ds have been transitory. The potential adverse effects
could include inhibition or delivery of additional therapies. If
electromagnetic interference (EMI) emitting from a telephone
does adversely affect an implanted ICD/CRT-D, moving the
telephone away from the immediate vicinity of the ICD/CRT-D
should restore normal operation. A recommendation to address
every specific interaction of EMI with implanted ICDs/CRT-Ds is
not possible due to the disparate nature of EMI.

implant.

1.4.9 Electronic Article Surveillance (EAS)

Equipment such as retail theft prevention systems may interact
with pulse generators. Patients should be advised to walk directly
through and not to remain near an EAS system longer than
necessary.

1.4.10 Home Appliances

Home appliances normally do not affect ICD/CRT-D operation if
the appliances are in proper working condition and correctly
grounded and shielded. There have been reports of the
interaction of electric tools or other external devices (e.g. electric
drills, older models of microwave ovens, electric razors, etc.) with
ICDs/CRT-Ds when they are placed in close proximity to the
device.

1.4.11 Home Monitoring®

BIOTRONIK’s Home Monitoring system is designed to notify
clinicians in less than 24 hours of changes to the patient’s
condition or status of the implanted device. Updated data may not
be available if:

16 Lumax Technical Manual

 The patient’s CardioMessenger is off or damaged and is

not able to connect to the Home Monitoring system
through an active telephone link

 The CardioMessenger cannot establish a connection to

the implanted device

 The telephone and/or Internet connection do not operate

properly

 The Home Monitoring Service Center is off-line (upgrades

are typically completed in less than 24 hours)

Patient’s Ability - Use of the Home Monitoring system requires
the patient and/or caregiver to follow the system instructions and
cooperate fully when transmitting data.

If the patient cannot understand or follow the instructions because
of physical or mental challenges, another adult who can follow the
instructions will be necessary for proper transmission.

Use in Cellular Phone Restricted Areas - The mobile patient
device (transmitter/receiver) should not be utilized in areas where
cellular phones are restricted or prohibited (i.e., commercial
aircraft).

Lumax Technical Manual 17

1.5 Potential/Observed Effects of the

Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative
to the implant procedure and chronic implant of the CRT-D:

 Air embolism
 Allergic reactions to

contrast media

 Arrhythmias
 Bleeding
 Body rejection

phenomena

 Cardiac tamponade
 Chronic nerve damage
 Damage to heart valves
 Device migration
 Elevated pacing

thresholds

 Extrusion
 Fluid accumulation
 Hematoma
 Infection
 Keloid formation
 Lead dislodgment

 Lead fracture/insulation

damage

 Lead-related thrombosis
 Local tissue

reaction/fibrotic tissue
formation

 Muscle or nerve

stimulation

 Myocardial damage
 Myopotential sensing
 Pacemaker mediated

tachycardia

 Pneumothorax
 Pocket erosion
 Thromboembolism
 Under sensing of intrinsic

signals

 Venous occlusion
 Venous or cardiac

perforation

18 Lumax Technical Manual

In addition, patients implanted with the ICD/CRT-D system may
have the following risks. These are the same risks related with
implantation of any ICD/CRT-D system:

 Acceleration of

arrhythmias (speeding
up heart rhythm caused
by the CRT-D)

 Dependency
 Depression
 Fear of premature

battery depletion (fear
that battery will stop
working before predicted
time)

 Fear of shocking while

awake

 Fear that shocking

ability may be lost

There may be other risks associated with this device that are
currently unforeseeable.

 Anxiety about the CRT-D

resulting from frequent
shocks

 Imagined shock (phantom

shock)

 Inappropriate detection of

ventricular arrhythmias

 Inappropriate shocks
 Potential death due to

inability to defibrillate or
pace

 Shunting current or

insulating myocardium
during defibrillation with
external or internal paddles

1.5.2 Observed Adverse Events

Reported Adverse Events are classified as either observations or
complications. Complications are defined as clinical events that
require additional invasive intervention to resolve. Observations
are defined as clinical events that do not require additional
invasive intervention to resolve.

1.5.2.1 Kronos LV-T Study

NOTE:

The Kronos LV-T CRT-D is an earlier generation of
BIOTRONIK devices. The Lumax CRT-Ds are based upon
the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs
(i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of
ICDs).

Lumax Technical Manual 19

s

The HOME-CARE Observational study, conducted outside the
US on the Kronos LV-T cardiac resynchronization defibrillator
(CRT-D) in patients with congestive heart failure (CHF) involved
45 devices implanted with a cumulative implant duration of
202 months (mean implant duration of 4.5 months).

Of the 31 adverse events reported, there have been
26 observations in 23 patients and 5 complications in 3 patients
with a cumulative implant duration of 202 months (16.8 patient­years). 6.7% of the enrolled patients have experienced a
complication with two patients experiencing 2 separate
complications. The rate of complications per patient-year was

0.30. 51% of the enrolled study patients had a reported
observation with 3 patients having more than 1 observation. The
rate of observations per patient-year is 1.54. Complications and
observations for the patient group are summarized in Table 2

Table 3

, respectively.

and

Table 2: Summary of Complications – Kronos LV-T

Category

Number

of

Patients

% of

Patient

Number

Per

patient-

year

Left Ventricular Lead Related

Dislodgement 1 2.2% 1
No Capture 1 2.2% 1

Total 2 4.4% 2

0.06

0.06

0.12

ICD Lead Related

Dislodgement 1 2.2% 1
Elevated Pacing

Threshold

1 2.2% 1

Total 2 4.4% 2

0.06

0.06

0.12

Unrelated to CRT-D or Leads

Hemathorax 1 2.2% 1

Total 1 2.2% 1

Overall

Complication Totals

Number of Patients = 45, Number of Patient-Years = 16.8

3 6.7% 5

0.06

0.06

0.30

20 Lumax Technical Manual

Table 3: Summary of Observations – Kronos LV-T

Category

Unsuccessful LV
lead implant

Elevated LV pacing
threshold

Phrenic nerve
stimulation

Elevated DFT
measurement

T-wave oversensing

Worsening CHF
Elevated RV pacing

threshold
Hepatitis

Arrhythmias
Cardiac

Decompensation

Number

of

Patients

%of

Patients

Number

8 17.8% 8 0.48

5 11.1% 5 0.30

3 6.7% 3 0.18

2 4.4% 2 0.12

2 4.4% 2 0.12
2 4.4% 2 0.12

1 2.2% 1 0.06

1 2.2% 1 0.06
1 2.2% 1 0.06

1 2.2% 1 0.06

per

patient-

year

All Observations 23 51.1% 26 1.54

Number of Patients = 45, Number of Patient-Years = 16

Two patient deaths were reported during the HOME-CARE
Observational Study. One death resulted from worsening heart
failure and the second death resulted from cardiogenic shock due
to ischemic cardiomyopathy. None of the deaths were related to
the implanted CRT-D system. There were no device explants
during the HOME-CARE Observational Study.

Lumax Technical Manual 21

1.5.2.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section and in

Section

which is an earlier version of the Lumax CRT-D/ICD families.
The clinical study data presented here is applicable because
the Lumax family are downsized versions of the
Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax
family is slightly different as compared to the Tupos LV/ATx
(and Tachos family) in the following areas:

 Reduced size from 50/48 cc to 40/35 cc
 Addition of Home Monitoring® functionality
 Addition of triggered pacing for biventricular pacing

 True three chamber pacing and sensing capabilities

The OPTION CRT/ATx study was a prospective, randomized,
multi-center study to demonstrate the safety and effectiveness of
the investigational Tupos LV/ATx Cardiac Resynchronization
Therapy Defibrillator (CRT-D) in patients with congestive heart
failure (CHF) and atrial tachyarrhythmias. All patients enrolled into
the clinical study were randomly assigned to either the study
group or the control group at a 2 to 1 ratio. Patients in the study
group were implanted with the Tupos LV/ATx. Patients in the
control group were implanted with a legally marketed ICD that
provides CRT.

1.6.2 was performed with the Tupos LV/ATx CRT-D,

modes

(CRT-Ds)

Of the 278 adverse events reported in the Tupos LV/ATx study
group, there have been 210 observations in 104 patients and 68
complications in 50 patients with a cumulative implant duration of

1240.4 months (101.9 patient-years). 37.6% of the enrolled study
patients have experienced a complication. The rate of
complications per patient-year is 0.67. 78.2% of the enrolled
study patients have a reported observation. The rate of
observations per patient-year is 2.06.

22 Lumax Technical Manual

Complications and observations for the Tupos LV/ATx study
group are summarized in Table 4

and Table 5. The total number
of patients may not equal the sum of the number of patients listed
in each category, as an individual patient may have experienced
more than one complication or observation.

Table 4: Summary of Complications – Tupos LV/ATx

Category

Number

of

Patients

Hematoma 4 3.01% 4 0.04
Pneumothorax 2 1.50% 2 0.02

Total 6 4.51% 6 0.06

Dislodgement 3 2.26% 3 0.03

Total 3 2.26% 3 0.03

High threshold/No
capture

2 1.50% 2 0.02

Diaphragmatic/Interc
ostal stimulation

1 0.75% 1 0.01

(RV)

Total 3 2.26% 3 0.03

High
threshold/Intermitten
t biventricular

11 8.27% 12 0.12

capture/No capture
Unable to implant
lead via coronary

11 8.27% 11 0.11

sinus
Dislodgement 4 3.01% 4 0.04
Diaphragmatic/Interc

ostal stimulation

1 0.75% 2 0.02

Total 27 20.3% 29 0.28

% of

Patients

Number of

Complications

Procedure Related

Atrial Lead Related

ICD Lead Related

LV Lead Related

Complications

per patient-year

Lumax Technical Manual 23

Table 4: Summary of Complications – Tupos LV/ATx

Category

Number

of

Patients

Infection 3 2.26% 7 0.07
Device migration 4 3.01% 4 0.04
Elective replacement

indicator reached
Inductions and
conversions
Unable to interrogate
device

4 3.01% 4 0.04

1 0.75% 1 0.01

1 0.75% 1 0.01

Total 12 9.02% 17 0.17

Total Procedure
and Device Related

43 32.33% 58 0.57

Other Medical Related

Non-CHF Cardiac
Symptoms
Ventricular
arrhythmias

4 3.01% 4 0.04

2 1.50% 3 0.03

Other medical 2 1.50% 2 0.02
Atrial arrhythmia 1 0.75% 1 0.01

Total 9 6.77% 10 0.10

Total – All Patients
and Categories

50 37.59% 68 0.67

% of

Patients

Complications

Device Related

Number of

Complications

per patient-year

Number of Patients = 133, Number of Patient-Years = 101.9

* 1 Unanticipated Adverse Device Effect (UADE) occurred with a
Tupos LV/ATx CRT-D during the OPTION clinical study. The device was
explanted after it was unable to be interrogated with the programmer
software and no pacing output was evident. The analysis showed an
inappropriately depleted battery and no anomalies with the IC module.
The battery depletion strongly suggests that the high voltage circuit was
activated over a prolonged period due to a single-bit execution path
failure. The current programmer software with Automatic Battery
Management (ABM) would have prevented the battery from becoming
completely depleted. There were no other instances of this failure
mechanism in Tupos LV/ATx devices.

24 Lumax Technical Manual

For the Tupos LV/ATx study group, there were 210 observations
in 104 patients with cumulative implant duration of 1240.4 months
(101.9 patient years). 78.2% of the enrolled study patients have a
reported observation. The rate of observations per patient-year
was 2.06. Table 5

summarizes by category each type of

observation for the study group.

Table 5: Summary of Observations – Tupos LV/ATx

Number

Category

Hematoma 10 7.52% 10 0.10

Cardiac arrest 2 1.50% 2 0.02
Unable to implant

system

Total 13 9.77% 13 0.13

Dislodgement 1 0.75% 1 0.01

High threshold 1 0.75% 1 0.01

Total 2 1.50% 2 0.02

High threshold/No
capture

Total 1 0.75% 1 0.01

High threshold/
Intermittent
biventricular capture/
No capture
Diaphragmatic/
Intercostal stimulation

Total 30 22.56% 32 0.31

of

Patients

Procedure Related

1 0.75% 1 0.01

Atrial Lead Related

ICD Lead Related

1 0.75% 1 0.01

LV Lead Related

24 18.05% 24 0.24

8 6.02% 8 0.08

% of

Patients

Number

per patient-

year

Lumax Technical Manual 25

Table 5: Summary of Observations – Tupos LV/ATx

Number

Category

Infection 1 0.75% 1 0.01
Inductions and

conversions
Inappropriate sensing 20 15.04% 20 0.20
Symptomatic with

biventricular pacing

Total 25 18.80% 29 0.28

Total Procedure,
Lead and Device
Related

Non-CHF Cardiac
Symptoms
Ventricular
arrhythmias

Other medical 26 19.55% 32 0.31

Atrial arrhythmia 14 10.53% 14 0.14

Dizziness 4 3.01% 4 0.04

Medication 5 3.76% 5 0.05

Worsening CHF 46 34.59% 46 0.45

Total 82 61.65% 133 1.31

Total – All Patients
and Categories

Number of Patients = 133 Number of Patient-Years = 101.9

of

Patients

Device Related

6 4.51% 6 0.06

2 1.50% 2 0.02

61 45.86% 77 0.76

Other Medical Related

21 15.79% 21 0.21

11 8.27% 11 0.11

104 78.20% 210 2.06

% of

Patients

Number

per patient-

year

26 Lumax Technical Manual

There have been 4 patient deaths reported for the control group
(out of 67 total control patients) and 10 patient deaths have been
reported for the study group (out of 133 total study patients).
None of the deaths were related to the implanted CRT-D system.
One patient in the control group died prior to receiving a
biventricular device implant. There is no significant difference
between the number of deaths in the study group versus the
control group (p = 0.777, Fisher's Exact Test, 2 sided). Table 6
provides a summary of reported patient deaths and Table 7
provides survival percentages by follow-up interval during the first
12 months of study participation.

Table 6: Summary of Patient Deaths

Category of

Death

Study

(N = 133)

Control

(N = 67)

Number of Patients Number of Patients

Sudden Cardiac 1 1

Non-Sudden

5 2

Cardiac

Non-Cardiac 4 1

All Causes

10 4

Figure 3 shows the associated Kaplan-Meier survival curves for

the study and control group. The significance level for the
difference between the two study groups based on a Log Rank
test was p = 0.795.

Lumax Technical Manual 27

Cumulative Survival

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

Log Rank = 0.795

Control

Study

211815129630

Survival Time (months)

Figure 3: Kaplan-Meier Survival Curves

Table 7 Survival Table

Study Group

(n = 133)

Control Group

(n = 66)

Number % Number %
Enrollment 133 100.00% 67 100.00%
3-month 131 98.50% 63 94.03%
6-month 127 95.49% 63 94.03%
12-month 123 92.48% 63 94.03%

1.6 Clinical Studies

The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.1)
supports the safety of the Lumax CRT-D/ICD device family.
Additionally, because the Tupos LV/ATx and the Lumax CRT-D
devices have identical CRT and ventricular ICD therapy, the
effectiveness results from the OPTION CRT/ATx IDE Clinical
study (Tupos LV/ATx, Section
the Lumax family.

1.6.2) support the effectiveness of

28 Lumax Technical Manual

1.6.1 Kronos LV-T Study

The purpose of the HOME-CARE Observational Study is to
demonstrate the safety of the CE-marked Kronos LV-T cardiac
resynchronization defibrillator (CRT-D) in patients with congestive
heart failure (CHF).

1.6.1.1 Methods

The multi-center, non-randomized observational study was
designed to evaluate the safety of the Kronos LV-T through an
analysis of the complication-free rate through three months.

HOME-CARE Observational Study Primary Endpoint was to

The
evaluate complications (adverse events that require additional
invasive intervention to resolve) related to the implanted CRT
system which includes the Kronos LV-T, the right atrial lead, the
right ventricular ICD lead, and the left ventricular lead

Inclusion Criteria

To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:

 Indication for Cardiac Resynchronization Therapy
 Sufficient GSM-network coverage in the patient’s area
 Age greater than or equal to 18 years

Exclusion Criteria

To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following:

 Permanent atrial fibrillation
 Myocardial infarction or unstable angina pectoris within

the last 3 prior to enrollment

 Planned cardio-surgical intervention within 3 months after

enrollment (e.g. PTCA, CABG, HTX)

 Acute myocarditis
 Life expectancy less than 6 months
 Pregnant or breast-feeding woman
 Drug or Alcohol abuse
 The patient is mentally or physically unable to take part in

the observational study

 No signed declaration of consent for the patient

Lumax Technical Manual 29

At the enrollment screening, the physician evaluated the patient
to verify that all inclusion/exclusion criteria were met in
accordance to the protocol and the patient signed the informed
consent. After successful enrollment, all patients were implanted
with the Kronos LV-T CRT-D. Evaluations at the One- and Three­month follow-ups included resting ECG, NYHA classification,
medications, and activation of Home Monitoring.

1.6.1.2 Summary of Clinical Results

The study involved 45 patients (37

males, 82.2%, and 8 females,

17.8%), with a mean age of 64 years (range: 36-79), a left
ventricular ejection fraction of 26 % (range: 15-43), NYHA Class
III (NHYA Class 1 (2.3%), Class II (11.4%), Class III (79.5%),
Class IV (6.8%)) and QRS duration of 154 ms (range: 84-208).

The mean implant duration was 4.5 months with a cumulative
implant duration of 202 months. The patient follow-up compliance
rate was 95.9% out of 221 required follow-ups.

Primary Endpoint

The safety of the Kronos LV-T was evaluated based on
complications (adverse events that require additional invasive
intervention to resolve) related to the implanted CRT system
which includes the Kronos LV-T, the right atrial lead, the right
ventricular ICD lead, and the left ventricular lead. 5 complications
were seen in 3 patients with cumulative implant duration of 202
months (16.8 patient-years). 6.7% of the patients had a reported
complication. The rate of complications per patient-year is 0.30.

The freedom from Kronos LV-T system-related complications is

93.3% with a two sided lower 95% confidence bound of 83.8%.
The null hypothesis is rejected, and it is concluded that the
complication-free rate is equivalent to 85% within 10%.

30 Lumax Technical Manual

1.6.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section was
performed with the Tupos LV/ATx CRT-D, which is an earlier
version of the Lumax CRT-D/ICD families. The clinical study
data presented here is applicable because the Lumax family
are downsized versions of the Tupos LV/ATx CRT-D and
Tachos ICD families. The Lumax family is slightly different as
compared to the Tupos LV/ATx (and Tachos family) in the
following areas:

 Reduced size from 50/48 cc to 40/35 cc
 Addition of Home Monitoring functionality
 Addition of triggered pacing for biventricular pacing

modes

 True three chamber pacing and sensing capabilities

1.6.2.1 Study Overview

The purpose of the prospective, randomized, multi-center
OPTION CRT/ATx study was to demonstrate the safety and
effectiveness of the investigational Tupos LV/ATx Cardiac
Resynchronization Therapy Defibrillator (CRT-D) in patients with
congestive heart failure (CHF) and atrial tachyarrhythmias.
Patients in the study group were implanted with a BIOTRONIK
Tupos LV/ATx. Patients in the control group were implanted with
any legally marketed CRT-D. Patients in both the study and
control groups were implanted with a legally marketed left
ventricular lead.

(CRT-Ds)

Lumax Technical Manual 31

1.6.2.2 Methods

Primarily, the study evaluates and compares the functional
benefits of CRT between the two randomized groups using a
composite endpoint consisting of a six-minute walk test (meters
walked) and quality of life measurement (assessed using the
Minnesota Living with Heart Failure Questionnaire). Relevant
measurements were completed twice for each patient: once at
the Baseline evaluation (two-week post implant follow-up) and
again at a six-month follow-up evaluation. The data collected
during this clinical study was used to demonstrate equivalent
treatment of CHF in both the study and control groups. This study
also evaluated other outcomes including: the effectiveness of
atrial therapy to automatically convert atrial tachyarrhythmias, the
percentage of time CRT is delivered, and other measures of CHF
status including NYHA classification, peak oxygen consumption
during metabolic exercise testing, and the rate of hospitalization
for CHF.

Inclusion Criteria

To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:

 Stable, symptomatic CHF status
 NYHA Class III or IV congestive heart failure
 Left ventricular ejection fraction  35% (measured within

Six-Months prior to enrollment)

 Intraventricular conduction delay (QRS duration greater

than or equal to 130 ms)

 For patients with an existing ICD/CRT-D, optimal and

stable CHF drug regimen including ACE-inhibitors and
beta-blockers unless contraindicated (stable is defined as
changes in dosages less than 50% during the last 30
days)

 Indicated for ICD therapy
 History or significant risk of atrial tachyarrhythmias
 Willing to receive possibly uncomfortable atrial shock

therapy for the treatment of atrial tachyarrhythmias

 Able to understand the nature of the study and give

informed consent

 Ability to tolerate the surgical procedure required for

implantation

32 Lumax Technical Manual

 Ability to complete all required testing including the six-

minute walk test and cardiopulmonary exercise testing

 Available for follow-up visits on a regular basis at the

investigational site

 Age greater than or equal to 18 years

Exclusion Criteria

To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following:

 Previously implanted CRT device
 ACC/AHA/NASPE indication for bradycardia pacing

(sinus node dysfunction)

 Six-minute walk test distance greater than 450 meters
 Chronic atrial tachyarrhythmias refractory to

cardioversion shock therapy

 Receiving intermittent, unstable intravenous inotropic

drug therapy (patients on stable doses of positive
inotropic outpatient therapy for at least One-Month are
permitted)

 Enrolled in another cardiovascular or pharmacological

clinical investigation

 Expected to receive a heart transplant within 6 months
 Life expectancy less than 6 months
 Presence of another life-threatening, underlying illness

separate from their cardiac disorder

 Acute myocardial infarction, unstable angina or cardiac

revascularization within the last 30 days prior to
enrollment

 Conditions that prohibit placement of any of the lead

systems

1.6.2.3 Summary of Clinical Results

A total of 200 patients were enrolled

in the OPTION CRT/ATx

clinical study at 25 sites:

There were 133 study patients and 67 active control patients in
this prospective, multi-center, randomized clinical study. For the
study group, there were 129 successful implants (91.4%) of the
Tupos LV/ATx CRT-D system. For the active control group, there
were 64 successful implants (92.2%) of the legally marketed
CRT-D systems.

Lumax Technical Manual 33

Patient Accountability

After randomization and enrollment, 7 patients (4 in the study
group and 3 in the control group) did not receive an implant. The
reasons for patients not receiving an implant are outlined in

Figure 4

.

Enrolled and Randomized

Patients

Study 133
Control 67

Implant Attempted

Study 130
Control 65

Successful implant

Study 129
Control 64

Patients completed 6-Month

Follow-up

Study 100
Control 49

No implant Attempted

Withdrawal of Consent

Study 2
Control 1

Not Meeting Inclusion Criteria

Study 1
Control 1

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Study 1
Control 0

Expired before Second Attempt

Study 0
Control 1

6-Month Follow-up Data

Patient Death before 6-Month

Study 7
Control 3

Withdrawal before 6-Month

Study 1
Control 2

Not Reached 6-Month FU

or Data Pending

Study 21
Control 10

Figure 4: Patient Accountability

Overall Results

 There were 192 endocardial and 19 epicardial leads

implanted in 193 patients. Investigators were allowed to
choose among any legally marketed LV lead according to
familiarity with the lead and patient anatomy. The
Tupos LV/ATx CRT-D was implanted with 7 endocardial
and 4 epicardial lead models from 6 different
manufacturers. There were no adverse events reported
attributable to lead-generator incompatibility.

34 Lumax Technical Manual

 The cumulative implant duration was 1240.4 months with

a mean duration of 9.6 months for the study group. The
cumulative implant duration is 596.5 months with a mean
duration of 9.3 months for the control group.

 For the study group, there have been 278 adverse events

(210 observations in 104 patients and 68 complications in
50 patients). There has been one unanticipated adverse
device effect reported.

 For the control group, there have been 105 adverse

events (81 observations in 44 patients and 24
complications in 19 patients). There have been no
unanticipated adverse device effects reported.

 There have been 10 patient deaths reported in the study

group and 4 patient deaths reported in the control group.
The clinical investigators have determined that no deaths
were related to the study device.

1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL

(Effectiveness)

The purpose of Primary Endpoint 1 is to evaluate the
effectiveness of the Tupos LV/ATx system in providing CRT as
measured by the average composite rate of improvement in six
minute walk test and QOL.

Table 8

presents the average composite rate of improvement in
six minute walk test distance and QOL score, the average 6­minute walk test distance and the average QOL score at Baseline
and at the Six-Month follow-up, as well as the average difference
in 6-minute walk test distance and QOL score between Baseline
and the Six-Month follow-up for the Study and Control Groups for
those patients with six minute walk test data and complete QOL
data at both Baseline and the Six-Month follow-up.

Lumax Technical Manual 35

Table 8: Composite of Six Minute Walk Test and QOL

(Effectiveness)

Category

Distance Walked at

Baseline

Distance Walked at

Six-Months

∆ Distance Walked

QOL Score at

Baseline

QOL Score at Six-

Months

∆ in QOL Score**

Study

Group

(N = 74)

Mean  SE

310.51 ±

10.89

340.77 ±

12.32

30.26 ±

10.40

17.27% ±

5.59%

44.39 ± 2.78 45.53 ± 4.13 0.817

28.68 ± 2.66 33.95 ± 4.35 0.279

15.72± 2.83

19.08% ±

12.21%

Control

Group

(N = 38)

Mean  SE

288.76 ±

15.37

301.84 ±

17.02

13.08 ±

13.05

8.71% ±

5.26%

11.58 ± 3.45

-13.42% ±

34.54%

P-value*

0.249

0.067

0.322

0.326

0.376

0.281

Composite Rate***

*The calculated p-values are associated with a Student's t-test (2-sided)
of the equality of means in the two groups, except for the p-value of the
composite rate, which is associated with a test of equivalence (non­inferiority).
**∆ in QOL Score is calculated as the average of the individual
differences between Baseline and Six-Months for each patient. Negative
values for mean ∆ QOL in percent are possible when positive mean
values for absolute changes in QOL are recorded. In some cases, small,
negative changes in absolute QOL scores resulted in relatively large
percentage changes.
***The Composite Rate (=(∆ Distance Walked (%) + ∆ QOL Score (%))/2)
is calculated for each patient and then averaged to obtain the Composite
Rates. For all calculations, a positive number represents improvement
from Baseline to Six-Months.

18.18% ±

7.07%

-2.36% ±

17.73%

0.030

36 Lumax Technical Manual

1.6.2.5 Effectiveness Endpoint Analysis and Conclusions

A composite rate of six minute walk test and QOL improvement
from Baseline to the Six-Month follow-up is evaluated as a
measure of CRT effectiveness. For this analysis both six minute
walk test and QOL are equally weighted at 50%.

The mean difference in the composite rate between study and
control group was 20.53% with an associated one-sided, 95%
confidence bound is (-6.10%). The p-value for non-inferiority
within 10% is 0.030. The analysis of the composite rate in six
minute walk test distance and QOL score demonstrates that the
study group is non-inferior to the control group and that the
primary effectiveness endpoint was met (p=0.030).

1.6.2.6 Primary Endpoint 2: Complication-Free Rate

(Safety

)

The purpose of Primary Endpoint 2 was to evaluate complications
(adverse events that require additional invasive intervention to
resolve) related to the implanted CRT system which includes the
Tupos LV/ATx, the right atrial lead, the right ventricular ICD lead,
the left ventricular lead, and the implant procedure. The target
complication-free rate at Six-Months is 85%.

Table 9 provides the categorized complication rates at 6-months

for the study and the control group as well as a comparison
between the study and the control group.

Lumax Technical Manual 37

Table 9: Complications at 6-Month – Study and Control

Study versus Control

Comparison

Delta 95% CI P-value

3.02% [-3.64%,

0.76% [-5.74%,

6.12% [-5.50%,

%

3.78
%

6.94% [-6.46%,

9.21% [-4.96%,

Category

Procedure
Related
Atrial Lead
Related
ICD Lead
Related
LV Lead
Related

Device
Related

Other
Medical
Related

Total
Procedure,
Lead and
Device
Related

Total

Study

N = 133

6 (4.51%) 1

3 (2.26%) 1

3 (2.26%) 0 (0%) 2.26% [-3.03%,

26

(19.55%) 9 (13.43%)

7 (5.26%) 5

9 (6.77%) 2

39

(29.32%)

46

(34.59%)

Control

N = 67

(1.49%)

(1.49%)

(7.46%) -2.20

(2.99%)

15

(22.39%)

17

(25.37%)

8.45%]

5.37%]

6.53%]

16.45%]

[-11.42%,

4.77%]

[-3.82%,

10.13%]

19.17%]

21.99%]

0.428

1.000

0.552

0.329

0.541

0.341

0.317

0.201

1.6.2.7 Primary Safety Enpoint Analysis and Conclusions

The observed procedure, lead and device related complication­free rate at 6 months was 70.68%. The 95% confidence interval
for the complication-free rate was [62.16%, 78.25%]. The lower,
one-sided 95% confidence bound for the complication-free rate
was 63.50%. Therefore the procedure, lead and device related
complication-free rate at 6 months did not meet the pre-specified
acceptance criterion for this endpoint.

38 Lumax Technical Manual

1.6.2.8 Post-hoc Safety Analysis

BIOTRONIK did not meet the pre-specified objective performance
criteria of 85% within 10% for the safety endpoint. Therefore, a
post-hoc safety analysis was conducted. It was noted that

79.80% (39 out of 49 events) of the complications were right atrial
lead, right ventricular ICD lead, left ventricular lead and procedure
related. The atrial, ICD and LV leads used during this study are
legally marketed devices.

This post-hoc analysis evaluated the LV lead complications that
were “related” or “possibly related” to the Tupos LV/ATx CRT-D,
but excludes the complications that were “not related” to the
Tupos LV/ATx device (see Table 9). There were 11 patients who
had an attempt to implant the LV lead, but the physician was
unsuccessful in either obtaining coronary sinus (CS) access or
unable to find a stable position for the LV lead. Additionally, there
were 4 patients with a documented LV lead dislodgement that
has no direct relationship to the implanted Tupos LV/ATx.

Table 10: Complications at 6-Months (Excluding LV Lead

Related) - Study versus Control

Difference

Study vs.

Control

8.36%

11.39%

Category

Procedure Related
Atrial Lead Related
ICD Lead Related
LV Lead Related
Device Related
Other Medical Related

Total Procedure,
Lead and Device

Related

Total

Study

N=133

Control

N=67

6 (4.51%) 2 (2.99%) 1.53%
3 (2.26%) 1 (1.49%) 0.76%
3 (2.26%) 0 (0%) 2.26%

11 (8.27%) 1 (1.49%) 6.78%

7 (5.26%) 5 (7.46%) -2.20%
9 (6.77%) 2 (2.99%) 3.78%

27

(20.30%) 8 (11.94%)

35

(26.32%)

10

(14.93%)

Lumax Technical Manual 39

The pulse generator related complication rate is higher in the
control group as compared to the study group. The complication
rates for procedure related, atrial lead related, ICD lead related,
LV lead related and other medical related are higher in the study
group as compared to the control group.

1.6.2.9 Post hoc Safety Analysis Conclusion

There are no clinically

substantial differences in the total
complication rate or in the rates for the different complication rate
categories between the study and the control group.

Table 11

compares this post-hoc Safety Endpoint analysis to

previous CRT-D clinical studies:

Table 11 Safety Endpoint Comparisons

CRT-D Study

BIOTRONIK OPTION
(Original Analysis)

BIOTRONIK OPTION
(Post-hoc Analysis)

Estimated

freedom from

Complications

Lower 95%

CI

@ 6mos.

70.68% 63.5% 75%

78.95% 72.29% 75%

95%

lower

bound

criteria

Medtronic Insync ICD 81.1% 77.6% 67%
Guidant Contak CD N/A N/A 70%
St. Jude Medical Epic

HF

93.4% 90.6% 70%

This analysis confirms that the safety profile of the Tupos LV/ATx
is within a similar range determined during trials of other legally
marketed CRT-D devices.

40 Lumax Technical Manual

1.6.2.10 Secondary Endpoint Results

1. The purpose of Secondary Endpoint 1 is to evaluate the

overall ability of the Tupos LV/ATx to appropriately convert
spontaneous AT (atrial tachycardia) and AF (atrial fibrillation).
The results from the OPTION study were compared to the
results from BIOTRONIK’s TACT study (P000009/S4, dated
09-09-2002) that demonstrated the effectiveness of these
atrial therapy features in the Tachos DR - Atrial Tx ICD.

Table 12

summarizes success rates for each individual atrial
tachyarrhythmia therapy type and overall success rate from
the OPTION study compared to the TACT study. The number
of episodes and patients receiving any therapy is less than
the total episodes of each therapy type, as episodes may
have included more than one type of therapy.

Table 12 Overall Atrial Conversion Rate

OPTION Study

Patients Success Episodes

Conversion

rate

ATP 3 3 5 60.0%

HF Burst 17 45 111 40.5%

Shock 12 30 34 88.2%

All

Therapies

25 78 129 60.5%

TACT Study

ATP 29 62 142 43.6 %

HF Burst 49 156 408 38.2 %

Shock 42 84 108 77.8 %

All

Therapies

66 302 542 55.7 %

The overall conversion rate and the conversion rates for each
therapy are comparable to the conversion rates observed in
the TACT study, demonstrating that the Tupos LV/ATx device
has similar atrial conversion capabilities as the legally
marketed Tachos DR – Atrial Tx ICD.

Lumax Technical Manual 41

2. The purpose of Secondary Endpoint 2 is to evaluate VT
(ventricular tachycardia) and VF (ventricular fibrillation)
detection times of the Tupos LV/ATx. This is a measure of the
ability of the ventricular detection algorithm to detect VT and
VF in an appropriate timeframe. This endpoint was evaluated
based on the review of electrograms following induced VT/VF
episodes. A comparison of data from the TACT study that
utilized the legally marketed Tachos DR – Atrial Tx ICD
(P000009/S4, dated 09-09-2002) to data collected during the
OPTION study for the Tupos LV/ATx was performed.

Table 13

summarizes and compares the results from these

two clinical studies.

Table 13: Summary of Detection Times

Detection

Time

Individual
Readings

Tachos DR -

Atrial Tx ICD

Mean (SE)/N

2.27 (0.06)/52 2.26 (0.06)/71 0.01

Tupos

LV/ATx Mean

(SE)/N

Difference

By Patient 2.27 (0.07)/26 2.24 (0.06)/35 0.03

The analysis demonstrates that the average detection times
of the Tupos LV/ATx are comparable to the detection times
observed with the legally marketed Tachos DR - Atrial Tx
ICD. Both devices utilize identical ventricular detection
algorithms and only sense with the right ventricular lead. This
clinical data demonstrates that the ventricular detection times
are similar in both devices.

3. The purpose of Secondary Endpoint 3 is to evaluate the
percentage of ventricular pacing (thus, CRT) as
demonstrated by the device diagnostics at required follow­ups. This data was based on diagnostic data stored by the
Tupos LV/ATx.

Table 14

summarizes the percentage of ventricular pacing
between follow-ups as shown by device diagnostics for
patients in the study group.

42 Lumax Technical Manual

Table 14: Percentage of Ventricular Pacing –

3-Month and 6-Month Follow-ups

Percentage of

Ventricular

Pacing

3-Months

Patients

(percentage)

6-Months Patients

(percentage)

<80% 9 (7.4%) 4 (4.0%)

81 – 85 % 4 (3.3%) 2 (2.0%)

86 – 90 % 13 (10.7%) 9 (9.1%)

91 – 95 % 19 (15.7%) 20 (20.2%)

96 – 100 % 76 (62.8%) 64 (64.7%)

Totals 121 (100%) 99 (100%)

The majority of the follow-ups (84.9%) show a percentage of
ventricular pacing of 91% or more at Six-Months.

4. The purpose of secondary endpoint 4 is to evaluate
improvement in functional capacity as measured by the six
minute walk test. The six minute walk test is a well-accepted
measure of functional capacity and exercise tolerance. Also,
this test more closely mimics the patient’s day-to-day
activities than maximal exercise testing.

Table 15

summarizes the six minute walk test distance at
Baseline and the Six-Month follow-up for patients in the study
group and the control group.

Lumax Technical Manual 43

Table 15: Six Minute Walk Distance

Distance

(meters)

Baseline

N

Mean  SE

Range

Median

Study Control

127

283.14  9.27
23 to 511

269.43  13.77
29 to 507

302.00

61

244.00

Six-Month

N

Mean  SE

Range

Median

* Student's t-test, 2-sided

93

329.73  10.82
78 to 596

335.00

44

310.70  15.49
91 to 489

313.00

There are no clinically relevant differences in the six minute
walk test results between the study and the control group.

5. The purpose of Secondary Endpoint 5 is to evaluate the
improvement in the patient’s NYHA classification. Table 16
summarizes the average improvement in NYHA from
Baseline to Six-Months for 140 patients that were able to
complete both NYHA classification evaluations.

Table 16: Improvement in NYHA Classification at Six-

Months from Baseline

NYHA Change During OPTION Study

Change in NYHA

Class

Improved 2 classes

Study Patients

(N=97)

(percentage)

Control Patients

(N=43)

(percentage)

10 (10.3%) 2 (4.7%)

Improved 1 class

Total improved

No change

Worsened 1 class

47 (48.5%) 20 (46.5%)

57 (58.8%) 23 (51.2%)

39 (40.2%) 20 (46.5%)

1 (1.0%) 1 (2.3%)

44 Lumax Technical Manual

The study and the control group have similar NYHA classes
and similar rates of improvement in NYHA class from
Baseline to the Six-Month follow-up.

6. The purpose of Secondary Endpoint 6 is to evaluate the rate
of hospitalization, for CHF and for all other causes. The
occurrence rate and reasons for hospitalization of the study
group were compared to the control group. To be consistent
with other large-scale clinical trials, clinical sites were
instructed to report hospitalizations for CHF using the
following definitions: 1) hospitalization for heart failure
management, 2) outpatient visit in which IV inotropes or
vasoactive infusion are administered continuously for at least
4 hours, or 3) emergency room (ER) visit of at least 12 hours
duration in which intravenous heart failure medications
including diuretics are administered.

Table 17

summarizes hospitalization, ER visits and outpatient

visits for enrolled patients.

Lumax Technical Manual 45

Table 17: Hospitalization, ER Visits and Outpatient Visits

Medical Visits

Hospital

Admissions

Patients

Hospitalizations

Patients

Hospitalizations

Emergency

Room Visits

Patients

Visits

Patients

Visits

Outpatient Visits

Patients

Visits

Patients

Visits

Study

(N=128)

CHF Related:

20 (15.6%)

All causes:

68 (53.1%)

CHF Related:

1 (0.8%)

All causes:

13 (10.1%)

CHF Related:

1 (0.8%)

All causes:

5 (3.9%)

28

76

1

16

1

5

Control

(N=65)

CHF Related:

5 (7.7%)

9
All causes:
29 (44.6%)

46

CHF Related:

0 (0.0%)

0
All causes:

2 (3.1%)

2

CHF Related:

0 (0.0%)

0
All causes:

2 (3.1%)

2

A large percentage of All Cause hospitalizations can be
attributed to pacing lead revisions, device infections, or other
device-related interventions (e.g., pocket revision or device
replacements for ERI or device recall). The CHF
hospitalization rate for both the study and control groups is
clinically acceptable considering the enrollment CHF status of
the patients.

46 Lumax Technical Manual

7. The purpose of Secondary Endpoint 7 is to evaluate the
observation rate. Observations are defined as clinical events
that do not require additional invasive intervention to resolve.
For the study group, there were 210 observations in 104
patients with cumulative implant duration of 1240.4 months
(101.9 patient years). 78.2% of the enrolled study patients
have a reported observation. The rate of observations per
patient-year is 2.06. For the control group, there were 81
observations in 44 patients with cumulative implant duration
of 596.5 months (49.0 patient years). 65.7% of the enrolled
control patients had a reported observation. The rate of
observations per patient-year was 1.65.

8. The purpose of Secondary Endpoint 8 is to evaluate peak
VO2 as a measure of effectiveness of the Tupos LV/ATx
system in providing CRT. The core lab was blinded to study
randomization assignments during evaluation of the results of
the cardiopulmonary exercise (CPX) testing in order to
minimize the potential for bias. According to the protocol, to
be included in the analysis, patients were required to attain a
respiratory exchange ratio (RER) of  1.

Table 18

provides a summary of peak VO2 results for 42
patients with CPX testing completed at Baseline and the Six­Month follow-up and with an RER of  1.

Lumax Technical Manual 47

Table 18: Peak VO2 Testing Results – Patients with RER

 1

Results Study Control

Peak VO2

(ml/kg/min)

N=32

Baseline:

Mean:

13.46 ± 0.57
Range:

6.9 to 21.1

Six-Month:

Mean:

13.39 ± 0.53
Range:

7.6 to 20.70

Difference:

Mean:

-0.06 ± 0.42
Range:

-7.9 to 4.9

N=10

Baseline:

Mean:

12.58 ± 0.75
Range:

8.0 to 14.8

Six-Month:

Mean:

12.89 ± 0.94
Range:

7.0 to 17.2

Difference:

Mean:

0.31 ± 0.67
Range:

-2.7 to 4.6

1.6.2.11 Multi-site Poolability and Gender Analysis

The OPTION CRT/ATx clinical report includes data from multiple
centers with centralized coordination, data processing, and
reporting at BIOTRONIK. All of the clinical centers followed the
requirements of an identical clinical protocol, and all of the clinical
centers used the same methods to collect and report the clinical
data. In order to justify pooling of the data from multiple centers,
several analyses were completed. All of the centers were divided
into two groups based on implant volume. Comparisons were
then made between the patient populations based on the results
of each of the endpoints. Additionally, analyses were performed
on the data collected in the OPTION CRT/ATx clinical
investigation in order to compare results between males and
females. The first type of analysis compared enrollment by patient
gender in each of the study and control groups. The second type
of analysis compared effectiveness outcomes in each gender.

The results of these analyses demonstrate poolability of the data
between sites. There were no significant differences in the
second primary endpoint or any of the secondary endpoints
between high and low volume implant centers.

48 Lumax Technical Manual

The gender distribution in this clinical investigation is consistent
within the study groups and includes a representative proportion
of female participants. There were no significant differences in
any of the primary or secondary endpoints between the male and
female population.

1.6.2.12 Conclusions

The IDE Clinical
safety and effectiveness of the Tupos LV/ATx CRT-D device is
equivalent to that of similar legally marketed CRT-D devices.
Although the study missed its primary safety endpoint, additional
post hoc analyses were conducted to reassure that the safety
profile of the device is comparable to other legally marketed
CRT-D devices.

study (OPTION LV/ATx) demonstrated that the

1.6.3 Lumax HF-T V-V Clinical Study

1.6.3.1 Study Overview

The Lumax HF-T V-V clinical study is a randomized, double­blinded, crossover, multi-center, prospective trial. The purpose of
the study is to assess the safety and efficacy of adding
programmable V-V delay biventricular pacing when used as part
of echo optimization of V-V timing (OPT). The assessment
consisted of comparing one-month periods of CRT with (OPT)
and without (SIM) V-V programmability and optimization in the
same patients to assess whether a statistically significant
increase of worsened HF status occurred during V-V adjustment.
The V-V delay feature is programmed to provide CRT through the
selection of the first chamber paced and adjustment of the V-V
delay. When V-V delay programmability is not available, CRT
provides simultaneous biventricular pacing (V-V delay is 0 ms).

Lumax Technical Manual 49

1.6.3.2 Methods

The study primarily evaluates and compares the functional
benefits of the Lumax HF-T with OPT versus the Lumax HF-T
with SIM using an endpoint that includes both a 6-minute walk
(6MW) test and quality of life (QOL) measurement assessed
using the Minnesota Living with Heart Failure questionnaire
(MLWHFQ). As such, relevant measurements are completed 3
times for each patient: once at the baseline evaluation (up to 14
days after enrollment), once at the 1-month follow-up (30 days
after baseline) and once at the 2-month follow-up (30 days after
the 1-month follow-up). Baseline data is collected with the
Lumax HF-T programmed to SIM.

6MW testing was chosen as a meaningful measure of CRT
therapy effect on HF status because 6MW has been shown to
improve during chronic CRT therapy (Olsson LG, Swedberg K,
Clark AL et al. Six minute corridor walk test as an outcome
measure for the assessment of treatment in randomized, blinded
intervention trials of chronic heart failure: a systematic review. Eur
Heart J 2005; 26:778–793.) Example improvements of 6MW
include increase in the range of 20 meters.

In this trial, the intent was to detect any loss of CRT benefit by
assessing the incidence of HF “worsening”, defined as reduction
of 35 meters distance on 6MW during CRT with V-V
programmability and optimization compared to during CRT
without V-V programmability and optimization.

QOL testing was chosen as a meaningful measure of CRT
therapy effect on HF status because QOL has been shown to
improve during chronic CRT therapy (Albouaini K, Egred M, Rao
A, et al. Cardiac resynchronisation therapy: evidence based
benefits and patient selection. Eur J Intern Med. 2008
May;19(3):165-72) Example magnitude improvements of QOL
include change in the range of 10 points.

In this trial, the intent was to detect any loss of CRT benefit by
assessing the incidence of HF “worsening”, defined as increase
of 10 points in QOL score by MLWHFQ during CRT with V-V
programmability and optimization compared to during CRT
without V-V programmability and optimization.

Worsening in the trial was defined as either a worsening (as
defined) in 6MW or in QOL score during CRT with V-V
programmability and optimization.

50 Lumax Technical Manual

The primary endpoint hypothesis required that a high proportion
of subjects remain “not worsened” when CRT with V-V
programmability and optimization was delivered compared to
when CRT without V-V programmability and optimization. A high
proportion was defined according to an Objective Performance
Criteria (OPC), derived from observations of how often stable
subjects in the BIOTRONIK Tupos LV/ATX CRT-D trial (OPTION)
experienced spontaneous worsening due to the underlying
disease among other factors.

During the Lumax V-V clinical study, the V-V optimization was
completed utilizing echocardiography specifically determining an
optimal V-V delay using the velocity time integral (VTI) to non­invasively measure stroke volume. The assessment was
performed by determining the V-V delay setting associated with
the largest VTI value. The VTI of the aortic flow is measured in
the apical 5 chamber view.

Prior to the V-V delay optimization procedure, each patient
underwent an optimization of AV timing. Following the AV timing
adjustment, this standardized procedure was followed for the
optimization of V-V delay:

1. Program the Lumax HF-T “Initially Paced Chamber”
parameter to either RV or LV based on preference.

2. Assess the VTI measurement at the following V-V delays
(additional V-V settings may be utilized at the investigator’s
discretion):

 100 ms
 80 ms
 60 ms
 40 ms
 20 ms
 0 ms

Note: Use the average VTI parameter over a 3 beat cycle and
wait 10 to 15 seconds between changing V-V delay settings.
Also, attempt to measure the VTI parameter within the same
patient respiratory cycle.

3. Record the VTI measurement associated with each V-V
delay setting

Repeat steps 1-3 for the remaining “Initially Paced Chamber”
parameters

Lumax Technical Manual 51

Select permanent “Initially Paced Chamber” and “V-V delay after
Vp” to reflect the maximum VTI measurement for final
programming.

Inclusion Criteria

To support the objectives of this investigation, the inclusion
criteria at the time of patient enrollment for this investigational
study included the following requirements:

 Meet the indications for therapy.
 Successfully implanted with a BIOTRONIK Lumax HF-T

CRT-D system and have received SIM for a minimum of
30 days prior to enrollment.

 Treated with stable and optimal CHF medications.
 Age ≥ 18 years.
 Able to understand the nature of the study and give

informed consent.

 Able to complete all testing required by the clinical

protocol, including the 6-minute walk test and QOL
questionnaire.

 Available for follow-up visits on a regular basis at the

investigational site.

Exclusion Criteria

To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following
requirements:

 Meet one or more of the contraindications.
 Have a life expectancy of less than 6 months.
 Expected to receive heart transplantation within 6

months.

 Have had more than 1 CHF-related hospitalization within

past 30 days.

 Currently receiving IV inotropic medications.
 Chronic atrial fibrillation.
 Enrolled in another cardiovascular or pharmacological

clinical investigation, except for FDA required post-market
registries.

 Any condition preventing the patient from being able to

perform required testing.

52 Lumax Technical Manual

 Presence of another life-threatening, underlying illness

separate from their cardiac disorder.

1.6.3.3 Summary of Clinical Results

The

study involved 122 patients (96 males, 78.7%, and 26

females, 21.3%), with a mean age of 67.1 years (range: 35-87).

The cumulative enrollment duration is 621.3 months with mean
enrollment duration of 5.1 months. The patient follow-up

compliance rate for all enrolled patients is 98.5% (394 of 400
required follow-ups).

1.6.3.3.1 Primary Endpoint 1: Effectiveness of the V-V Delay

Feature

The primary endpoint was intended

to detect whether V-V
programmability and optimization contributed to significantly more
patients with “worsened” HF. Worsened was defined as:

 For 6MW, reduction of 35 meters distance on 6MW

during CRT with V-V programmability and optimization
compared to during CRT without V-V programmability
and optimization

 For QOL score, increase of 10 points in QOL score by

MLWHFQ during CRT with V-V programmability and
optimization compared to during CRT without V-V
programmability and optimization

 For each patient, i.e. as a responder’s analysis, the

occurrence of either worsened 6MW or QOL score during
CRT with V-V programmability and optimization.

Table 19

presents the mean 6-minute walk test distances and
QOL scores for Group 1 and Group 2 patients at the baseline, 1­month and 2-month follow-ups. Table 19

reports unpaired patient
data for information purposes, with the primary endpoint analysis
utilizing paired data from the 1-month and 2-month follow-ups.

Lumax Technical Manual 53

The analysis of the primary effectiveness endpoint is an intention­to-treat analysis based on the responder classification of changes
in the MLWHFQ and 6-minute walk distance between periods of
SIM and OPT, obtained at the 1-month and 2-month follow-ups.

Table 20

presents the percentage of all patients worsened and
not worsened to evaluate the effectiveness of OPT vs. SIM
utilizing the QOL and 6-minute walk responder classification. A
total of 106 out of the 110 patients that completed the primary
endpoint follow-up met the primary endpoint analysis based on
paired QOL and 6-minute walk data at the 1-month and 2-month
follow-up visits.

Table 19. QOL and 6-Minute Walk Test Results (Effectiveness)

Category Group 1 Group 2

QOL score at baseline

QOL score at 1-month
follow-up

QOL score at 2-month
follow-up

Distance walked at
baseline (m)

Distance walked at 1­month follow-up (m)

Distance walked at 2­month follow-up (m)

N = 60

35.4 ± 23.0

N = 57

31.2 ± 24.0
OPT

N = 58

32.6 ± 25.5

SIM

N = 61

328.9 ± 152.8

N = 58

343.9 ± 161.8
OPT

N = 57

341.1 ± 152.6

SIM

N = 53

30.0 ± 21.6

N = 54

30.1 ± 22.5
SIM

N = 52

25.9 ± 19.8

OPT

N = 54

309.1 ± 139.7

N = 54

337.6 ± 160.7
SIM

N = 51

334.7 ± 148.9

OPT

54 Lumax Technical Manual

Table 20. QOL and 6-Minute Walk Responder Classification

(Effectiveness)

QOL

Group 1

(N = 56)

Group 2

(N = 52)

Total

(N = 108)

Worsened 9 (16.1%) 6 (11.5%) 15 (13.9%)

Not worsened 47 (83.9%) 46 (88.5%) 93 (86.1%)

6-Minute Walk (N = 56) (N = 51) (N = 107)

Worsened 14 (25.0%) 15 (29.4%) 29 (27.1%)

Not worsened 42 (75.0%) 36 (70.6%) 78 (72.9%)

Composite (N = 55) (N = 51) (N = 106)

Worsened 21 (38.2%) 18 (35.3%) 39 (36.8%)

Not worsened 34 (61.8%) 33 (64.7%) 67 (63.2%)

The estimate of the proportion of subjects who were classified as
“Not Worsened” was 63.2% (67/106). The lower, exact, one-sided
95% confidence bound for this observed proportion is 54.8%. The
difference between the performance goal of 63% and 54.8% is

8.2%. This is lower than the pre-specified clinically significant
difference () of 12%.

1.6.3.3.2 Primary Endpoint 2: Safety of the V-V Delay
Feature

The purpose of Primary Endpoint 2 is to evaluate adverse events
that require additional invasive

intervention to resolve, specifically
related to the V-V delay feature of the Lumax HF-T. These
adverse events include any software issues related to V-V delay
programming or any adverse event that occurs after V-V delay
optimization and that can be directly attributed to the use of the
V-V delay feature.

There have been 0 reported complications related to the V-V
delay feature for the 122 patients enrolled into the study.

Lumax Technical Manual 55

The observed complication-free rate was 100.0%. The lower,
exact, one-sided 95% confidence bound for this observed rate is

97.6%. This exceeds the pre-specified rate (90% - δ) required for
demonstrating non-inferiority.

1.6.3.4 Conclusions

cumulative enrollment duration is 621.3 months with a mean

The
duration of 5.1 months. Sixty-one (50.0%) of the patients have
been enrolled for 91-180 days.

The proportion of subjects who are “Not Worsened” while their
device was programmed to OPT was found to be not inferior to
the performance goal of 63% within 12%. In addition, there have
been 0 complications reported regarding the Lumax HF-T V-V
delay feature.

The data received and analyzed demonstrates the general safety
of the Lumax HF-T V-V timing feature, with 0 complications
reported as caused by the feature. Also, the data received and
analyzed demonstrates the effectiveness of the Lumax HF-T V-V
timing feature, by providing evidence of non-inferiority to
simultaneous biventricular pacing in a responder classification.

1.6.4 TRUST Clinical Study

1.6.4.1 Study Overview

The TRUST study is a multi-center, prospective and randomized
trial. The purpose of the study was to demonstrate that the use of
the BIOTRONIK Home Monitoring system (HM) can safely reduce
the number of regularly scheduled office follow up visits,
compared to the conventional method of ICD follow-up. The
assessment consists of comparing the number of in-office follow­ups for patients with HM (HM group) versus patients without HM
(Control group). With the use of HM, the number of in-office follow
up visits per year could be reduced from an expected five
scheduled office follow up visits (3, 6, 9, 12 and 15 months) to two
visits (3 and 15 months). Additionally, the time from onset to
evaluation of arrhythmias in both groups was compared. It was
expected that evaluation of cardiac events in the HM arm would
occur earlier than those in the Control group.

56 Lumax Technical Manual

1.6.4.2 Methods

All enrolled patients received a BIOTRONIK ICD with Home
Monitoring/IEGM-Online technology and were randomized to
either Group 1 (Home Monitoring (HM)) or Group 2 (No Home
Monitoring (Control)) using a randomization ratio of 2:1.

Group 1 (HM)

Device evaluations for scheduled follow-ups, patient-initiated
inquiries and event triggered notifications were performed with
HM/IEGM Online. Patients were scheduled for office device
interrogations only at the 3 month and 15 month follow-up points
(following the HM online check). At 6, 9 and 12 months, a HM
check was performed first. Investigators may then elect to
perform an office device interrogation if they determine that it is
necessary after reviewing the HM data.

Group 2 (Control)

Patients were evaluated using conventional, calendar-based
office visits at 3, 6, 9, 12 and 15 months post-implant. Interim
visits were made according to physician discretion (e.g. following
any ICD discharges or symptoms). Home Monitoring was
programmed OFF for the duration of the study.

HM Event Triggered Device Evaluations

Investigators with patients in Group 1 (HM) may receive HM
notifications in response to pre-programmed events such as VT1
detected and SVT detected. Upon the receipt of a HM Event
Notification, investigators reviewed the notification and the
associated information on the HM/IEGM-Online website and
recorded the type of event and what type of action, if any, was
taken as a result of this notification.

Patient-Initiated Device Evaluations

Investigators may be contacted by the patient for
device/arrhythmia-related care (e.g. perceived device discharge,
symptoms). For patients in Group 1 (HM), investigators triaged
the complaint using the Home Monitoring website. Investigators
recorded if the information from Home Monitoring was sufficient.
For patients in Group 2 (Control), the complaint was assessed
per standard of care or normal clinic procedures.

Lumax Technical Manual 57

Primary Endpoints

The purpose of primary endpoint 1 (HM efficacy) was to compare
the number of in-office ICD follow-ups for patients in Group 1
(HM) to the conventional, calendar-based method of ICD follow­up as in Group 2 (Control).

The purpose of the primary endpoint 2 (safety) was to compare
the Safety Event Rate (SER), which includes death, incidence of
strokes and events requiring surgical interventions (e.g. device
explants or lead revision) between the two groups.

Secondary Endpoints

The purpose of secondary endpoint 1 was to compare AF, VT
and VF events between Group 1 and Group 2 in terms of the
number, categories, and detection time relative to onset.

Inclusion Criteria

To support the objectives of this investigation, the inclusion
criteria at the time of patient enrollment for this investigational
study included the following requirements:

 Implanted within the last 45 days or being considered for

implant with a BIOTRONIK ICD with Home
Monitoring/IEGM-Online technology

 Able to utilize the HM system throughout the study
 Ability to give informed consent
 Geographically stable and able to return for regular

follow-ups for fifteen (15) months

 At least 18 years old

Exclusion Criteria

To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following
requirements:

 Patients who do not fulfill all inclusion criteria
 Patients who are pacemaker dependent
 Currently enrolled in any other cardiac clinical

investigation.

58 Lumax Technical Manual

Clinical Events Committee

The Clinical Events Committee (CEC) is an advisory review board
comprised of three physicians that are not participating in the
TRUST Study who reviewed and adjudicated all deaths, strokes,
surgical interventions, and cardiac adverse events that occur
during the study. The CEC also reviewed all divergent
classifications of actionable vs. non-actionable office follow up
visits between the physician and BIOTRONIK, and reviewed a
random sampling of 1% of office follow up visits in which there is
no disputed classification.

1.6.4.3 Summary of Clinical Results

The study involved

1443 patients (1038 males, 71.9%), with a

mean age of 63.5 years (range: 20-95). The cumulative

enrollment duration is 18,367 months with mean enrollment
duration of 12.7 months. The patient follow-up compliance rate for

all enrolled patients is 87.5% in Group 1 and 78.8% in Group 2.

1.6.4.3.1 Primary Endpoint 1: Home Monitoring

Effectiv

eness

The purpose of primary endpoint 1 (HM efficacy) was to compare
the number of in-office ICD follow-ups for patients in Group 1
(HM) to the conventional, calendar-based method of ICD
follow-up as in Group 2 (Control).

Detailed primary endpoint 1 results are presented in Table 21

Table 21: Primary Endpoint Group 1 vs. Group 2

Group 1

(HM)

Group 2

(Control)

No. of

Pts**

898

414

Scheduled Unscheduled Total

n = 991

1.3 ± 1.0 per pt yr

13.1% actionable

n = 1110

3.0 ± 1.1 per pt yr

10.7% actionable

Office Follow-up Visits

n = 401

0.6 ± 1.7 per pt yr

29.7% actionable

n = 117

0.4 ± 1.4 per pt yr

29.1% actionable

p value < 0.001 0.032

* Up to and including 12 month follow-up data
** Number of patients that have contributed at least 1 follow-up

.

1.9 ± 1.9
per pt yr

3.4 ± 1.7
per pt yr

< 0.001

Lumax Technical Manual 59

Analysis

The comparison of the number of 3, 6, 9, and 12 month and
unscheduled office follow-up visits in Group 1 versus Group 2
showed that there was an average number of 1.9 office follow-up
visits on a per year basis in Group 1 (HM) and an average
number of 3.4 office follow-up visits on a per year basis in Group
2 (Control). Therefore, the null hypothesis (HØ) can be rejected,
indicating that the average number of office visits per year is
statistical significantly less in the HM group than in the Control
group (p < 0.001). The primary effectiveness endpoint was met.

1.6.4.3.2 Primary Endpoint 2: Safety Event Rate

The purpose of the primary endpoint 2 was to

compare the Safety
Event Rate (SER), which includes death, incidence of strokes and
events requiring surgical interventions (e.g. device explants or
lead revision) between the two groups.

Table 22

patients for 12 months post-enrollment. Figure 5

summarizes the Safety Event Rate for the study

shows these

data in a Kaplan-Meier analysis.

Table 22: Safety Event Rate Comparison

Safety Event Rate* Group 1 Group 2 p value**

Type of Event

Death
Stroke
Surgical

36/608 (5.9%)

2/574 (0.3%)

57/605 (9.4%)

18/245 (7.3%)

22/239 (9.2%)

3/227(1.3%)

0.440

0.141

1.000

intervention

Any Event

95/643 (14.8%) 42/256 (16.4%) 0.539

* Only includes events occurring within 12 months of enrollment
** 2-sided Fisher Exact test

60 Lumax Technical Manual

Figure 5: Safety Event Rate Kaplan Meier

Analysis

The safety event rate for a 12-month duration was 14.8% for
Group 1 (HM) and 16.4% for Group 2 (Control), with a non­inferiority p-value of 0.005. Therefore, the safety event rate for
HM Group was non-inferior to the safety event rate for the Control
Group within 5%. The upper, one-sided 95% confidence bound
for the difference was 2.7%.

A rejection of the null hypothesis indicates that the safety event
rate for Group 1 (HM) is equivalent (non-inferior) to that of Group
2 (Control).

1.6.4.3.3 Secondary Endpoint 1: Early Detection of Cardiac

ents (AF, VT & VF)

Ev

The purpose of secondary endpoint 1 was to compare AF, VT
and VF events between Group 1 and Group 2 in terms of the
number, categories, and detection time relative to onset.

Lumax Technical Manual 61

Table 23 compares the time from onset to evaluation of the first

AF, VT and VF events for each patient that have occurred in each
group, as well as the first of any type of event for each patient in
each group. Figure 6

illustrates the time from onset to evaluation

of arrhythmic events in a box plot graph.

Table 23: Time from First Event Onset to Evaluation

Time from Event Onset

to Evaluation of First

Event/Patient

Group 1

N=972

Group 2

N=471

p value

AF

Median
Mean ± SD (days)
Min
Max
# of patients with events

5.0

25.2 +/- 34.2
0

171

73 (7.5%)

39.5

46.8 +/- 33.7
1

114

28 (5.9%)

p < 0.001
p = 0.005

VT1 & VT2

Median
Mean ± SD (days)
Min
Max
# of patients with events

2.0

12.9 +/- 33.8
0

256

149 (15.3%)

32.0

46.6 +/- 46.9
0

245

53 (11.2%)

p < 0.001
p < 0.001

VF

Median
Mean ± SD (days)
Min
Max
# of patients with events

1.0

10.5 +/- 22.2
0

145

236 (24.3%)

35.5

45.0 +/- 47.0
0

287

92 (19.5%)

p < 0.001
p < 0.001

SVT

Median
Mean ± SD (days)
Min
Max
# of patients with events

2.0

16.6 ± 27.4
0

108

94 (9.7%)

39.0

42.1 ± 35.6
0

157

35 (7.4%)

p < 0.001
p < 0.001

62 Lumax Technical Manual

Figure 6: Median Time from Onset to Evaluation of

Arrhythmic Events

Analysis

The mean time from onset to evaluation of first AF, VT, and VF
events in Group 2 is greater than the mean time from onset to
evaluation of first AF, VT, or VF events in Group 1. A rejection of
the null hypothesis for AF, VT and VF event types indicates that
the mean time from onset to evaluation of the first AF, VT and VF
events in Group 1 is significantly less than the mean time from
onset to evaluation of the first AF, VT and VF events in Group 2.
P-values are =0.005, <0.001 and <0.001 respectively.

1.6.4.4 Conclusions

Use of HM in Group 1 resulted in an average of 1.9 office



visits per patient year in the 12 months post-implant, versus
an average of 3.4 office visits per patient year in Group 2, a
44% reduction in office visits. The average number of office
visits is significantly less in the HM group than in the Control
group (p < 0.001).

Lumax Technical Manual 63

 The safety event rate for a 12 month duration for Group 1

(HM) was non-inferior to the safety event rate for Group 2
(Control) within 5% (p = 0.005). The upper, one-sided 95%
confidence bound for the difference was 2.7%.

 The mean time from onset to evaluation of AF, VT and VF

events indicates that those events for Group 1 patients are
evaluated in significantly less time when compared to Group
2 patients (AF p = 0.005, VT p < 0.001, VF p < 0.001).

1.6.5 Deikos A+

NOTE:

The clinical study information included in this section was
performed with the Deikos A+ ICD and the Kainox VDD ICD
lead. Due to the similarities in detection and therapy a clinical
study of the Lumax 540 VR-T DX with the Kainox A+ was not
performed.
The Deikos A+ was formed on the Tachos DR platform,
whereas the Lumax 540 VR-T DX was formed on the
Lumax DR-T platform. Both ICDs are designed to be used
with a VDD lead. In this study, the Kainox VDD lead (single
shock RV shock coil and dual atrial floating dipoles) was
implanted. In order to enhance the intrinsic signal from the
floating dipoles, both ICDs contain an atrial sensing amplifier.
The signal is amplified 4 times in the Deikos A+ and 5 times
in the Lumax 540 VR-T DX.
Both the Kainox VDD and the Kainox A+ ICD leads have
identical floating electrodes in the atrium and identical pacing
electrode tip, ring and shock electrodes designed for
placement in the right ventricle. The minor differences are in
the ventricular shock coil (Kainox A+ coil has a slightly larger
surface area, and the surface is not coated with fractal
iridium).

64 Lumax Technical Manual

1.6.5.1 U.S. Clinical Study

1.6.5.1.1 Patients Studied

The Single-Lead ICD system clinical study involved 9 patients (7

and 2 female) with a mean age of 58.8 years (range: 25 to

males
83 years). 66.7% presented with ventricular
fibrillation/polymorphic ventricular tachycardia as their primary
tachycardia. The Single-Lead ICD system was selected for the
diagnostic value of the atrial EGMs in 88.9% of the patients.

1.6.5.1.2 Methods

feasibility clinical investigation was designed to evaluate the

The
quality of atrial signals obtained using the Single-Lead ICD. The
study was also designed to evaluate the safety and effectiveness
of the Single-Lead ICD system to detect and treat monomorphic
ventricular tachycardia (MVT), polymorphic ventricular
tachycardia (PVT), ventricular fibrillation (VF), and bradycardia.
The specific predefined objectives of the investigation included
UADE-free survival rate, appropriate bradycardia sensing and
pacing, detection and treatment of ventricular tachyarrhythmias
and appropriate atrial sensing during activities of daily living.

1.6.5.1.3 Results

The mean implant

duration was 6.1 ± 9.4 months with a
cumulative implant duration of 54.5 months. There were 5
patients followed for over six months and 2 patients followed for
over three months. The patient follow-up compliance rate was
100%, 43 out of 43 required follow-ups.

Table 24

provides a summary of the results of the study group.

Table 24: Clinical Study Results

Description Results

UADE-free Survival Rate 100% (9/9)

Lumax Technical Manual 65

Description Results

Complication Rate 11.1% (1/9)

Appropriate Atrial Sensing Rate1 97.6% (41/42)

Appropriate Atrial Sensing during 24-hour
Holter Test

Appropriate Atrial Sensing during
Exercise Treadmill Test

Detection and Conversion of Ventricular
Tachyarrhythmias

2

100% (9/9)

100% (6/6)

100% (68/68)

1.6.5.2 European Clinical Study

1.6.5.2.1 Patients Studied

The European Deikos A+/Kainox VDD lead clinical study involved
82 patients (66 males and 16 female) with a mean age of 61.8
years (range: 29 to 84 years).

42.7% presented with
monomorphic ventricular tachycardia as their primary
tachycardia.

1

The investigator determined the appropriateness of atrial sensing. The rate is
determined by the number of appropriate atrial sensing evaluations divided by
the total number of evaluations.

2

Conversion data were collected in the clinical study for both induced and
spontaneous ventricular tachyarrhythmia episodes. Therefore, both types of
tachyarrhythmia episodes were included in the analysis.

66 Lumax Technical Manual

1.6.5.2.2 Study Objectives

This clinical investigation was designed to collect information on
the performance and function of the Deikos A+/Kainox VDD ICD
system. The specific predefined objectives of the investigation
included the rate of inappropriate, i.e. unnecessary deliveries of
antitachycardia therapy due to supraventricular tachycardia
(SVT), the tachyarrhythmia conversion efficacy of the system with
activated SMART Detection™ algorithm, the rate of appropriate
atrial sensing and the morbidity rate.

1.6.5.2.3 Results

The mean implant

duration was 8.9 ± 4.4 months with a
cumulative implant duration of 732 months. No unanticipated
adverse events were reported during the study. There were two
deaths reported, which were unrelated to the implanted device. A
summary of the results obtained during the evaluation is provided
in Table 25

.

Table 25: OUS Clinical Study Results

Description Results

UADE-free Survival Rate 100% (82/82)

Complication Rate 19.5% (16/82)

Inappropriate Therapies with SMART
Detection™ algorithm ON Rate

Inappropriate Therapies with SMART
Detection™ algorithm OFF Rate

94.8% (234/250)

84.7% (133/157)

Appropriate Atrial Sensing Rate1 92.7% (165/211)

Detection and Conversion of Ventricular
Tachyarrhythmias

2

100% (211/211)

1

The investigator determined the appropriateness of atrial sensing. The rate is
determined by the number of appropriate atrial sensing evaluations divided by the
total number of evaluations.

2

Conversion data were collected in the clinical study for both induced and
spontaneous ventricular tachyarrhythmia episodes. Therefore, both types of
tachyarrhythmia episodes were included in the analysis.

Lumax Technical Manual 67

1.7 Patient Selection and Treatment

1.7.1 Individualization of Treatment

 Determine whether the expected device benefits

outweigh the possibility of early device replacement for
patients whose ventricular tachyarrhythmias require
frequent shocks.

 Determine if the device and programmable options are

appropriate for patients with drug-resistant
supraventricular tachyarrhythmias (SVTs), because drug­resistant SVTs can initiate unwanted device therapy.

 Direct any questions regarding individualization of patient

therapy to your BIOTRONIK representative or
BIOTRONIK technical services at 1-800-547-0394.

The prospective patient’s size and activity level should be
evaluated to determine whether a pectoral or abdominal implant
is suitable. It is strongly recommended that candidates for an
ICD/CRT-D have a complete cardiac evaluation including EP
testing prior to device implant to gather electrophysiologic
information, including the rates and classifications of all the
patient’s cardiac rhythms. When gathering this information,
delineate all clinically significant ventricular and atrial arrhythmias,
whether they occur spontaneously or during EP testing.

If the patient’s condition permits, use exercise stress testing to do
the following:

 Determine the maximum rate of the patient’s normal

rhythm.

 Identify any supraventricular tachyarrhythmias.
 Identify exercise-induced tachyarrhythmias.

The maximum exercise rate or the presence of supraventricular
tachyarrhythmias may influence selection of programmable
parameters. Holter monitoring or other extended ECG monitoring
also may be helpful.

68 Lumax Technical Manual

If the patient is being treated with antiarrhythmic or cardiac drugs,
the patient should be on a maintenance drug dose rather than a
loading dose at the time of pulse generator implantation. If
changes to drug therapy are made, repeated arrhythmia
inductions are recommended to verify pulse generator detection
and conversion. The pulse generator also may need to be
reprogrammed.

Changes in a patient’s antiarrhythmic drug or any other
medication that affect the patient’s normal cardiac rate or
conduction can affect the rate of tachyarrhythmias and/or efficacy
of therapy.

If another cardiac surgical procedure is performed prior to
implanting the pulse generator, it may be preferable to implant the
lead system at that time. This may prevent the need for an
additional thoracic operation.

1.7.2 Specific Patient Populations

Pregnancy - If there is a need to image the device, care should

be taken to minimize radiation exposure to the fetus and the
mother.

Nursing Mothers - Although appropriate biocompatibility testing
has been conducted for this implant device, there has been no
quantitative assessment of the presence of leachables in breast
milk.

Geriatric Patients - Most (about 71%) of the patients receiving a
CRT-D or ICD in the clinical studies detailed in this manual were
over the age of 60 years (see Clinical Studies).

Handicapped and Disabled Patients - Special care is needed in
using this device for patients using an electrical wheel chair or
other electrical (external or implanted) devices.

1.8 Patient Counseling Information

The implanted devices are subject to random component failure.
Such failure could cause inappropriate shocks, induction of
arrhythmias or inability to sense arrhythmias, and could lead to
the patient’s death.

Persons administering CPR may experience the presence of
voltage on the patient’s body surface (tingling) when the patient’s
CRT-D/ICD system delivers a shock.

Lumax Technical Manual 69

A patient manual is available for the patient, patient’s relatives,
and other interested people. Discuss the information in the
manual with concerned individuals both before and after pulse
generator implantation so they are fully familiar with operation of
the device. (For additional copies of the patient manual, contact
BIOTRONIK at the address listed in this manual.)

1.9 Evaluating Prospective CRT-D/ICD

Patients

The prospective ICD/CRT-D implant candidate should undergo a
cardiac evaluation to classify any and all tachyarrhythmias. In
addition, other patient specific cardiac information will help in
selecting the optimal device settings. This evaluation may include,
but is not limited to:

 an evaluation of the specific tachycardia rate(s)
 the confirmation and/or evaluation of any supraventricular

arrhythmias or bradyarrhythmias

 the evaluation of various ATP and cardioversion

therapies

 the presence of any post-shock arrhythmias, and
 an evaluation of the maximum sinus rate during exercise.

If a patient’s drug regimen is changed or adjusted while the
CRT-D/ICD is implanted, additional EP testing may be required to
determine if detection or therapy parameter settings are relevant
and appropriate.

Empirical changes to the detection or therapy parameters should
be assessed based on patient safety. Some changes may
necessitate a re-assessment of sensing, pacing, or arrhythmia
conversion treatment. Thorough technical knowledge of
BIOTRONIK CRT-D/ICDs, additional CRT-D/ICD experience, and
individual medical judgment will aid in determining the need for
additional testing and follow-up.

70 Lumax Technical Manual

2. Device Features

The Lumax family feature set is presented under the following
sub-headings: Tachyarrhythmia Detection, Tachyarrhythmia
Redetection/Acceleration, Tachyarrhythmia Therapy,
Tachyarrhythmia Termination, Bradycardia Therapy, EP Test
Functions and Special Features. The features apply to all
members of the Lumax family except where specifically
referenced differently.

CAUTION

Programmed Parameters – Program the device

parameters to appropriate values based on the patient’s
specific arrhythmias and condition.

2.1 SafeSync Telemetry

The Lumax 700/740 and 600/640 models offer ”wandless”
communication between the device and the programmer by using
radio frequency (RF) telemetry, in addition to the currently
available telemetry used by applying the programming head
(PGH) over the implanted device. This function is called SafeSync
Telemetry.

SafeSync Telemetry can be used with the Renamic programmer
or with the ICS 3000 programmer (using the SafeSync Module,
an external communication module).

To Establish SafeSync Telemetry contact:

The programmer (or the SafeSync module) must be no more than
9 feet (3 m) from the device; ideally there should be no obstacles
between the patient and the programmer.

 Switch on RF telemetry on the programmer. Select:

Preferences→Connectivity→RF telemetry→
Interrogation→ON. Or, select: More→Lumax→
Telemetry→RF, during the follow-up.

 Apply the programming head for about 2 seconds until

successful initialization is displayed on the programmer:

Lumax Technical Manual 71

The SafeSync symbol is displayed in the navigator and
the signal strength is displayed in green bars on the
information line. The SafeSync telemetry status is shown
in five increments: 1 bar = 20% up to 5 bars = 100%. A
weak contact shows only one bar in green, whereas all
five bars are shown in green when there is optimal
contact. The bars are shown in gray if RF telemetry is
lost. The display should have at least three green bars.
Otherwise, it is recommended to reposition the
programmer until an adequate signal strength is
achieved.

 Remove the programming head.

 To restore the SafeSync Telemetry after an interruption

during follow-up or after a programmer restart: select
Special→Continue RF session on the start screen to
restore the most recent active session. This SafeSync
Telemetry session must not have been inactive for longer
than five minutes, since the device's SafeSync Telemetry
activity is automatically switched off after five minutes of
inactivity.

Note: If the SafeSync Telemetry session has been
inactive for more than 5 minutes, the programming
head must be reapplied to reinitialize the SafeSync
Telemetry.

To End SafeSync Telemetry contact:

To end the SafeSync Telemetry session:

 End Follow-up session

To switch to telemetry via the programming head (PGH):

72 Lumax Technical Manual

 Apply the programming head on the patient over the

device.

 Select: More→Lumax→ Telemetry→PGH.

Power Consumption Consideration:

SafeSync telemetry requires somewhat more power than
telemetry via the programming head. Power consumption during
implantation corresponds to approximately 10 days of service
time and consumption during 20-minute follow-up corresponds to
approximately 3 days. As a result:

 Do not establish SafeSync Telemetry sessions

unnecessarily.

 After 5 minutes without input, SafeSync Telemetry

switches to the economy mode. In order to re-establish
telemetry from the economy mode, select “Close” in the
pop-up window with the patient’s name:

 Check the battery capacity of the device at regular

intervals.

Lumax Technical Manual 73

2.2 Cardiac Resynchronization Therapy

(CRT)

HF versions only

For Cardiac Resynchronization Therapy (CRT), a sensing/pacing
lead is placed in the right atrium, while an ICD lead is placed in
the right ventricle. The third lead is positioned to pace the left
ventricle. When connected together, this system provides
coordinated, simultaneous stimulation of the right and left
ventricles. This resynchronization therapy is designed to
coordinate the contraction of both ventricles, which allows the
heart to contract more efficiently. As a result, patients with CHF
and intraventricular conduction delay may have a greater ability to
complete physical activities thus improving their quality of life.

As a result of the device design and header configuration,
ventricular pacing pulses can be delivered between the right/left
ventricular lead tip electrodes simultaneously (cathode) and at
programmed intervals. In some configurations the ring of the right
ventricular lead works as LV anode. Ventricular sensing primarily
uses the poles of the right ventricular lead tip and ring. This
design avoids sensing of ventricular activity twice during a single
cardiac cycle (double counting) in patients with a wide QRS
complex. However, for diagnostic purposes and LV pacing
protection the Lumax HF devices can be programmed to sense in
the left ventricle.

Atrial Channel

The Lumax ICDs/CRT-Ds pace and sense in bipolar
configuration, between the atrial lead’s tip and ring electrodes. A
bipolar atrial lead must be used to ensure reliable sensing of atrial
activity.

Ventricular Channel

The Lumax HF devices can be programmed to pace in both the
right and left ventricle (as well as RV only). The Lumax HF
primarily senses in a bipolar configuration in the right ventricle.
However, for diagnostic purposes and LV pacing protection the
Lumax HF devices can be programmed to sense in the left
ventricle.

Potential Ventricular lead configurations are provided in Table 26

.

74 Lumax Technical Manual

Table 26. Lead Configurations

Configuration Explanation

Sensing

RV Only

Sensing takes place between
the tip and ring electrodes of
the right ventricular lead.

Pacing

Pacing

LV Only

RV & LV
Together (BiV)

RV Only

Sensing takes place between
the tip and ring electrodes
(bipolar) or the tip electrode of
the left ventricular lead and the
CRT-D housing (unipolar).

Pacing configuration is
programmable between the tip
and ring electrodes of the right
and left ventricular leads.
See Figure 7

Pacing takes place between
the tip and ring electrodes of
the right ventricular lead.

See Figure 7

Figure 7 Programmable Pacing Configurations

Lumax Technical Manual 75

For CRT to be effective, ventricular pacing must occur. Therefore,
AV delays must be programmed short enough to override intrinsic
ventricular contractions. Additional information to further optimize
AV delays can be obtained with echocardiography.

CRT can be programmed ON or OFF via the programmer using
the [Ventricular Pacing] parameter. Ventricular Pacing
Configuration allows standard right ventricular [RV] (CRT = OFF)
pacing or Cardiac Resynchronization Therapy [BiV] (CRT = ON).

The Lumax HF CRT-D can provide triggered biventricular pacing.
This is a functional expansion of the basic ventricular modes
(DDD(R); DDI(R); VDI(R); VDD(R); VVI(R)) used for biventricular
pacing. The “RVs triggering” was designed to ensure CRT is
delivered even when rapid intrinsic activation interferes with
pacing, such as in the case of conducted atrial fibrillation. This
function triggers LV pacing (Vp) after intrinsic sensing (RVs) in
the right ventricle. Triggered pacing can be programmed to react
to only normal RV sensed events or to right ventricular
extrasystoles as well as normal RV sensed events. The maximum
trigger rate is normally limited by the programmed UTR
(+20bpm), but can also be programmed to function up to a
separate and higher maximum trigger rate.

V-V Delay Programming

V-V delays should be programmed based on optimization of the
echocardiographic parameter Aortic Valve Velocity Time Integral,
evaluating the full range of available delays, as was performed in
the clinical study demonstrating the safety and effectiveness of
this feature. RV pre-excitation may cause a decline of LV
function.

The V-V delay features for the Lumax HF-T devices include the
ability to program the following parameters “first chamber paced,”
which allows either the right or the left ventricle to be paced first,
and “VV delay” for setting a delay between the left and right
ventricular pacing pulses (programmable range: 0 ms … (5ms) …
100 ms).

Suggested optimization procedure:

During the V-V clinical study assessment was performed by
determining the V-V delay setting associated with the largest VTI
value. The VTI of the aortic flow is measured in the apical 5
chamber view.

76 Lumax Technical Manual

Prior to the V-V delay optimization procedure, each patient
underwent an optimization of AV timing. Following the AV timing
adjustment, this standardized procedure was followed for the
optimization of V-V delay:

1. Program the Lumax HF-T “Initially Paced Chamber”

parameter to either RV or LV based on preference

2. Assess the VTI measurement at the following V-V delays

(additional V-V settings may be utilized at the physician’s
discretion):

 •100 ms
 • 80 ms
 • 60 ms
 • 40 ms
 • 20 ms
 • 0 ms

Note: Use the average VTI parameter over a 3 beat cycle and
wait 10 to 15 seconds between changing V-V delay settings.
Also, attempt to measure the VTI parameter within the same
patient respiratory cycle.

3. Record the VTI measurement associated with each V-V

delay setting

Repeat steps 1-3 for the remaining “Initially Paced Chamber”
parameters

Select permanent “Initially Paced Chamber” and “V-V delay after
Vp” to reflect the maximum VTI measurement for final
programming.

2.3 Sensing (Automatic Sensitivity Control)

The Lumax ICDs/CRT-Ds use Automatic Sensitivity Control
(ASC) to adjust the input stage sensitivity threshold for each
channel to appropriately detect the various cardiac signals. The
characteristics of the sensing circuitry have been optimized to
ensure appropriate sensing during all potential cardiac rhythms.

Lumax Technical Manual 77

Cardiac signals vary in amplitude; therefore detection thresholds
cannot be static. With the Automatic Sensitivity Control (ASC)
every paced/sensed event is measured, and the upper and lower
thresholds are re-set accordingly (also known as beat-by-beat
adaptation). The ASC begins by tracking the cardiac signals (R
and P-waves) during the sensed refractory periods. The peak
values measured during this time are used to set the sensing
thresholds during the active detection periods.

2.3.1 Right Ventricular Sensitivity Settings

There are three programmable preset options for setting the
sensitivity of the right ventricular input stage. The sensitivity
selections are designed to adapt the parameters of the input
stage to various signal conditions. The predefined parameter sets
are described in Table 27

Table 27: Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for most

Enhanced
T Wave
Suppression

Enhanced
VF Sensitivity

Typically, the upper threshold is reset with each sensed R-wave,
but in order to ensure that pacing does not occur during an
episode of VF, the ASC behaves differently with paced events.
Each paced event is followed by a paced refractory period after
which the ventricular threshold is set to the minimum
programmed value.

.

patients, especially for those with
measured R-wave amplitude of 3 mV.

This setting offers suppression of T-wave
oversensing. This mode should not be
used on patients with the following
conditions:

 Sinus rhythms with small signal

amplitudes, R-waves 4 mV

 VF with highly fluctuating signal

amplitudes.

This setting enhances VF detection, in
cases of highly fluctuating signal
amplitudes. It is not to be used for patients
that have sinus rhythms containing large
amplitude T-waves.

78 Lumax Technical Manual

For example, the upper threshold is set at 50% of the measured
R-wave for the Standard sensitivity setting following the 100 ms
sensed refractory period. The upper threshold decays 0.125 mV
every 250 ms through the T-wave discrimination period (hold of
upper threshold: 360 ms). After the T-wave discrimination period,
the threshold is decreased to the lower threshold. The lower
threshold is set to 25% of the measured peak R-wave. The lower
threshold then decreases 0.125 mV every 500 ms until the
Minimum Threshold is reached or until the next sensed (or paced)
event.

For Lumax 600/640 and 700/740 devices, the decrease is
controlled on a percentage basis. Every 156 ms 87.5% of the
threshold reference. Initially this is the maximum amplitude. Hold
of upper threshold: 400 ms.

Figure 8 Automatic Sensitivity Control with Standard Setting

Figure 8

provides an illustration of Automatic Sensitivity Control
with the sensitivity programmed to Standard. The tracked R –
wave is measured to be 6.0 mV, following the sensed refractory
period the upper threshold is set to 3.0 mV. After the T-wave
discrimination period, the threshold is further reduced to 1.5 mV.
Both the Upper and Lower Thresholds decay over time, but the
Minimum Threshold is never violated. Nominally, the minimum
threshold is set to 0.8 mV, but it can be adjusted by the user.

Lumax Technical Manual 79

The Enhanced VF Sensitivity setting is specifically designed to
improve VF detection when the VF signal is very small. Two
adjustments are made to ASC with this setting:

 The T-wave discrimination period (hold of upper

threshold) is decreased to 100 ms [110 ms for Lumax
600/640 and 700/740 models], thus eliminating the Upper
Threshold.

 The decay rate of the Lower Threshold is increased to

0.125 mV every 250 ms. This is not applicable for the
Lumax 600/640 and 700/740 models.

These adjustments ensure that the threshold reaches the lower
values more quickly in order to assure that all VF signals are
sensed appropriately.

The Enhanced T-Wave Suppression setting is specifically
designed to avoid double counting of each QRS-T complexes
during normal sinus rhythms. With sensitivity programmed to
Enhanced T-Wave Suppression:

 High pass filtering is increased to reduce low frequency

signal components such as T-waves and respiratory
artifacts.

 The Upper Threshold is increased to 75% of the

measured R-wave.

 The Upper Threshold may not retrigger with each sensed

event, it is only triggered when the new sensed R-wave
crosses the 50% point of the previous measured R-wave.

2.3.2 Minimum Right Ventricular Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to
a programmable value. Nominally, the minimum threshold is set
to 0.8 mV, but it can be adjusted from 0.5 to 2.5 mV.

2.3.3 Atrial Sensitivity Settings

DR and HF versions only

The primary option for setting the sensitivity of the atrial input
stage is “Standard”. When atrial sensing is active, the sensitivity
is set to “Standard” for most patients, which is designed to adapt
the parameters of the input stage to various signal conditions.
The available settings are described in Table 28

.

80 Lumax Technical Manual

Table 28: Atrial Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning atrial lead.

Inactive This setting deactivates the atrial channel

for sensing, EGM telemetry and Holter
recording and is typically used when no
atrial lead is implanted.

Typically, the upper threshold is reset with each sensed P-wave,
but in order to ensure that pacing does not occur during an
episode of AF/VF, the ASC behaves differently with paced
events. Each paced event is followed by a paced refractory
period after which the atrial threshold is set to the minimum
programmed value.

2.3.4 Minimum Atrial Threshold

This parameter limits the minimum sensitivity of the ICD/CRT-D to
a programmable value. Nominally, the minimum threshold is set
to 0.4 mV, but it can be adjusted from 0.2 to 2.0 mV.

2.3.5 Left Ventricular Sensitivity Settings

HF versions only

The primary option for setting the sensitivity of the left ventricular
input stage is “Standard”. When LV sensing is active, the
sensitivity is set to “Standard” for most patients, which is designed
to adapt the parameters of the input stage to various signal
conditions. The available settings are described in Table 29

.

Lumax Technical Manual 81

Table 29: Left Ventricular Sensitivity Settings

Setting Definition for Use

Standard This setting is recommended for all

patients with a functioning left ventricular
lead.

Inactive This setting deactivates the left ventricular

channel for sensing, EGM telemetry and
Holter recording and is typically used when
no LV lead is implanted.

2.3.6 Minimum Left Ventricular Threshold

This parameter limits the minimum sensitivity of the CRT-D to a
programmable value. Nominally, the minimum threshold is set to

0.8 mV, but it can be adjusted from 0.5 to 5.0 mV.

2.3.7 Far Field Protection

DR and HF versions only

This parameter blanks the atrial channel of the ICD/CRT-D to the
period before and after each ventricular event. This blanking
period is programmable separately based on whether the
ventricular event is a paced or sensed event and is designed to
prevent sensing of ventricular signals with the atrial leads.

CAUTION

Far-field sensing of signals from the atrium in the

ventricular channel or ventricular signals in the atrial channel
should be avoided by appropriate lead placement,
programming of pacing/sensing parameters, and maximum
sensitivity settings. If it is necessary to modify the Far Field
Blanking parameter, the parameter should be lengthened
only long enough to eliminate far-field sensing as evidenced
on the IEGMs. Extending the parameter unnecessarily may
cause undersensing of actual atrial or ventricular events.

2.3.8 Additional Sensing Parameters

The parameters of the Additional Sensing Parameters menu are
to provide additional flexibility for physicians to non-invasively
correct over/undersensing situations. The ranges and nominal
values are located in the Technical Specifications in Section

6.

82 Lumax Technical Manual

Upper Threshold (A, RV & LV) - This feature allows the user to
change the upper sensing threshold level (UT in Figure 8

) from
the nominal value of 50% of the sensed R-wave/P-wave
amplitude to either 75% or 87.5% of the R-wave/P-wave value.
This feature is used in the ventricle for example to eliminate
oversensing of large T-waves. This is not applicable to the Lumax
600/640 and 700/740 models.

Hold of Upper Threshold (RV & LV) - This parameter
determines when the sensing decrement begins after an event
(small step-down on the 50% threshold before LT in the figure
above). This parameter “holds” the threshold at a constant value
(UT in Figure 8

) for the programmed time. Maximum Hold Time is
programmable from 100 to 600 ms in Lumax 300/340 & 500/540
and 110 to 500 ms in the Lumax 600/640 & 700/740 models (T­Wave discrimination period). Additionally, the Lumax 600/640 &
700/740 models are separately programmable between the
paced and sensed signals.

Lower Threshold (A, RV & LV)- This feature allows the user to
change the lower sensing threshold (labeled LT in Figure 8

) from
the default value of 25% of the sensed R-wave/P-wave amplitude
to either 12.5 or 50% of the measured R-wave/P-wave value. This
is not applicable to the Lumax 600/640 and 700/740 models. This
feature is also used in the ventricles to alleviate T-wave
oversensing and/or undersensing of small amplitude events (e.g.,
fine VF).

Blank after atrial pacing (RV) - This feature is used to eliminate
sensing of artifacts after atrial paced events. Blank Post atrial
Pace in the RV is programmable from 50 to 100 ms. For the left
ventricle, this parameter is equal to the safety window time
(100 ms).

VES Discrimination after As - This feature is used to correctly
identify and classify ventricular extrasystoles (VES). With each
atrial sensed event (also with Ars falling into PVARP) a special
timing interval is started for the ventricle, if the subsequent
ventricular event does not fall within the AV delay or the
programmed VES discrimination interval, it is classified as a VES.

LV T-wave Protection - Used to eliminate unintended pacing in
the vulnerable period of the left ventricle. This feature is only used
when left ventricular sensing is active. HF versions only.

Lumax Technical Manual 83

2.4 Automatic Threshold Measurement

(ATM)

Lumax 500/540 Models only

The Lumax 500/540 models have an automatic threshold
measurement (ATM) feature for determining ventricular pacing
thresholds. This feature is separately programmable for the right
(RV) and left (LV) ventricles.

ATM is initiated once each day, typically during the nighttime
while the patient is normally sleeping. It can measure the right
and the left ventricular pacing thresholds and stores this
information for use in trends of daily threshold values. This
information is available on the programmer during in-office follow­ups and via BIOTRONIK’s Home Monitoring system. The
permanent pacing amplitude is not adjusted by the ATM feature.

The ATM features of Lumax 500/540 are based on the evaluation
of the morphology of the ventricular evoked response (VER) to
determine if the pacing pulse has captured the myocardium. In
order to measure the pacing threshold, a sequence of two
algorithmic steps is carried out:

 Signal Quality Check (SQC)

 Threshold Measurement

The signal quality check determines if the morphology of the
evoked response of a captured beat is sufficiently different from
the morphology of the evoked response of a non-captured pace.
If the SQC is sufficient (i.e., if the algorithm can clearly distinguish
between capture and non-capture), then the automatic threshold
measurement is activated by initiating a series of pacing pulses.
The amplitude of these pulses is continuously decreased until a
loss of capture is detected. When loss of capture is detected a
back-up pulse is delivered (right ventricle only) to avoid
ventricular pauses caused by the threshold measurement.

84 Lumax Technical Manual

2.4.1 Signal Quality Check

During the Signal Quality Check, five single effective pacing
pulses are delivered. These pulses are followed by five double
pulses. The second pulse of each double pulse is delivered into
the refractory phase of the ventricle (as a non-capturing pulse).
The VER morphology of the single pulses and the second pulse
of the double pulses are assessed. The signal quality check is
successful if the single pulses are recognized as capturing pulses
and the second pulses of the double pulses are classified as non­capturing pulses. The AV delay of the 2 x 5 pulses is shortened to
50 ms after pace and by 15 ms after sense, in order to avoid
ventricular fusion beats which would otherwise disturb the SQC. If
the SQC is successful, then the threshold measurement is
started, if not, the SQC is repeated once again after 30 minutes.

2.4.2 Threshold Measurement

The threshold measurement begins by delivering pulses at the
programmed pacing amplitude. The pulse amplitude is decreased
in steps of 0.6 Volts (V) each until loss of capture is detected.
During the loss of RV-capture sequence, a backup pulse is
issued. The back-up is set to a value of the programmed pacing
amplitude plus 0.6 V with a pulse width of 1.0 ms. There are no
backup paces for left ventricular ATM (LV-ATM).

The pulse amplitude is then set to the last effective value (0.6
Volts above the initial non-capture level) and then subsequent
pacing pulses are reduced in 0.1 V steps until loss of capture
reoccurs. The last effective pacing amplitude is then recorded as
the pacing threshold.

2.4.3 Loss of Capture Detection

In order to ensure against ATM loss of capture detection due to
an isolated non-capture event (i.e. as a result of VES), loss of
capture is only declared if two out of three consecutive cycles
show loss of capture.

2.4.4 ATM in Lumax HF-T Models

If the device is programmed to biventricular pacing (BiV), the RV
ATM functions in the RV mode as described above. The LV ATM,
if active, is initiated after the RV ATM is complete. For the LV
ATM, the left ventricle is stimulated first with a VV delay of 50 ms
and then completed in a similar manner.

Lumax Technical Manual 85

Lumax 600/640 & 700/740 Models only

2.4.5 RV & LV Capture Control

RV & LV Capture Control uses the determined pacing threshold
to adjust the permanent pulse amplitude. The new permanent
pulse amplitude is composed of the determined pacing threshold
plus a safety margin (1.0 or 1.2 V) and is automatically
programmed in the ICD.

2.5 Ventricular Tachyarrhythmia Detection

The Lumax ICDs/CRT-Ds detect and measure the rate of sensed
cardiac signals to discriminate ventricular tachyarrhythmias from
supraventricular tachycardias, sinus rhythm or sinus bradycardia.
This is accomplished through programmable rate detection
parameters in the device. When a tachyarrhythmia is present, the
ICD/CRT-D classifies the arrhythmia and delivers the appropriate
therapy. If a tachyarrhythmia continues following the first therapy
attempt, then the ICD/CRT-D will redetect the tachyarrhythmia
and deliver subsequent therapies as necessary.

WARNING

Unwanted Shocks – Always program ICD therapy to OFF

prior to handling the device to prevent the delivery of serious
shocks to the patient or the person handling the device
during the implant procedure.

Classification of cardiac signals is accomplished primarily by
measuring the cardiac cycle length (R-R, P-R and P-P). In
addition, the ICD/CRT-D can also utilize abrupt changes in rate or
irregularity of the cardiac signal to further differentiate ventricular
tachyarrhythmias. Each detected ventricular tachyarrhythmia is
classified into one of the following zones:

 VT-1 Lower rate ventricular tachycardia
 VT-2 Higher rate ventricular tachycardia
 VF Ventricular fibrillation

Each rhythm class is programmable to a separate rate with the
zone limit defining the lowest rate in each class. The upper rate
limit of each class is equal to the zone limit of the next higher
class, creating a continuous range of rate classes.

86 Lumax Technical Manual

2.5.1 VF Classifications

Detection of ventricular fibrillation (VF) utilizes programmable X
out of Y criterion. For the Lumax 300/340 & 500/540 models, both
X and Y are programmable. For the Lumax 600/640 and 700/740
models there are fixed combinations of X out of Y criterion. If X
number of intervals within the sliding window (defined by Y) are
shorter than the programmed VF rate interval (>bpm), VF is
detected. After fibrillation is detected, the programmed therapy
sequence for VF is initiated.

Nominal settings for classification of ventricular fibrillation (VF)
are 8 of 12 intervals; meaning that within a sample window of
12 intervals, 8 intervals must meet or exceed the VF zone rate
criteria.

2.5.2 VT Interval Counters

The VT Interval Counters are separately programmable for VT-1
and VT-2 rate classifications. The Counter: Detection is the
number of intervals required to declare a tachyarrhythmia as VT.
A tachyarrhythmia must meet the rate/interval criteria and the
programmed Counter/Detection criteria, in addition to any other
detection enhancements to be declared a tachycardia.

2.5.3 VT Classification

Both VT-1 and VT-2 classification zones utilize separately
programmable detection parameters. Classification of VT-1 or
VT-2 is based on the last interval average preceding declaration
of tachyarrhythmia detection. If this average falls within the VT-1
zone, the programmed VT-1 therapy is delivered. If the average
falls within the VT-2 limits, the programmed VT-2 therapy is
delivered. If additional detection parameters are activated, each
of these supplemental criteria must also be satisfied before a VT
rhythm can be classified and treated.

Lumax Technical Manual 87

The ICDs/CRT-Ds may be programmed to use ventricular-only
information, or both atrial and ventricular information for the
discrimination of ventricular tachyarrhythmias. With SMART
Detection™ turned ON, the Lumax ICDs/CRT-Ds use atrial and
ventricular signals for discrimination of fast heart rhythms. With
SMART Detection™ turned OFF, only the ventricular rate is used
to discriminate between ventricular rhythm classes. If SMART
Detection is enabled, this algorithm evaluates all cardiac signals
within the VT range and increments the VT Sample Count for all
intervals that are deemed VT. A full description of SMART
Detection™ is provided in Section

In addition, when the Lumax senses the programmed number of
consecutive intervals (termination count) within the sinus rate
zone, all tachyarrhythmia detection criteria, including the VT
sample counters are reset.

2.5.4.

2.5.4 SMART Detection™

DR and HF versions only

This discrimination algorithm enhances VT-1 and VT-2 detection
by applying a series of tests to the sensed cardiac signal. SMART
Detection™ is intended to discriminate VT from a variety of
supraventricular arrhythmias that are conducted to the ventricle
and that would otherwise satisfy VT-1 or VT-2 rate detection
criteria.

First, the average ventricular rate is compared to the average
atrial rate. In the event that the measured ventricular rate is faster
than the atrial rate, the device immediately declares the rhythm a
VT and delivers programmed ventricular therapy for the detected
VT zone.

In the event that an atrial rate is faster compared to the ventricular
rate one of three tests are performed:

Ventricular rhythm stability, (see Stability in Section
ventricular signal is unstable, then the rhythm is declared a
supraventricular tachyarrhythmia, (SVT) and ventricular therapy is
typically withheld.

If the ventricular signal is stable, and the atrial rate is a multiple of
the ventricle rate, then the rhythm is declared a supraventricular
tachyarrhythmia (SVT) and ventricular therapy is typically
withheld.

2.5.6 if the

88 Lumax Technical Manual

If the ventricular rhythm is stable and the atrial rate is not a
multiple of the ventricular rate, then the rhythm is declared a VT
and ventricular tachycardia therapy is delivered.

In the event that both the atrial and ventricular signals are
detected at the same rate, a series of additional discrimination
tests are applied.

2.5.5 Onset

Another detection enhancement that may be used independently
(VT-1 or VT-2, when SMART Detection is active) or as an adjunct
to the SMART Detection™ algorithm is the Onset parameter.
This parameter measures abrupt changes in ventricular cycle
length to discriminate between sinus tachycardias and ventricular
and atrial tachyarrhythmias, which characteristically begin with an
abrupt change in cardiac rate.

This feature allows therapy to be withheld if a sinus tachycardia
rate crosses into one of the VT zones.

2.5.6 Stability

In VT-1 and VT-2 zones, the purpose of STABILITY is to assist in
discriminating between stable ventricular tachyarrhythmias and
supraventricular tachyarrhythmias that conduct irregularly to the
ventricles. STABILITY evaluates sudden changes in the
regularity of cardiac events (R-R and P-P intervals) on a beat by
beat basis. The STABILITY criterion compares the current
measured interval with the three preceding cardiac intervals. If a
difference between the current interval and each of the three
preceding intervals is less than the stability range, then the
current intervals are stable.

The SMART Detection™ algorithm utilizes both atrial and
ventricular STABILITY as integral parts of the discrimination
algorithm. Therefore, when SMART Detection™ is enabled, the
STABILITY parameter must also remain enabled and set to 12%.

2.5.7 Sustained VT Timer

The Sustained VT Timer can be programmed between
30 seconds and 30 minutes (or to OFF) for the Lumax 300/340 &
500/540 models and 1 min to 30 minutes (or to OFF) in the
Lumax 600/640 and 700/740 models. When the timer expires,
therapy is initiated regardless of the detection enhancements.

Lumax Technical Manual 89

The Sustained VT parameter is intended to force tachycardia
therapy in cases where a cardiac rhythm meets the VT rate
criteria but does not satisfy one or more detection enhancement
criterion (Onset, SMART Detection, or Stability) for an extended
duration. This “safety” timer is initiated within one of the VT
zones. If the programmed Sustained VT time period expires
without tachycardia detection, redetection is initiated without
utilizing the detection enhancements.

A simple up/down counter is used to initiate the safety timer. The
counter is incremented by one when an interval falls into a VT
zone and decrements by one when an interval falls into the sinus
zone. When the counter reaches a number equal to the
programmed VT detection counter, the safety timer is started.
The timer runs until the programmed time expires and therapy is
delivered or until the timer is reset. The timer is reset with initial
detection or VT termination.

The safety timer is not used in redetection. If initial detection was
due to the safety timeout and SMART Redetection is
programmed “ON”, then SMART Detection will not be used for
redetection.

2.5.8 VT Monitoring Zone

The VT1 zone can be programmed to monitor for non-sustained
arrhythmias not requiring therapy. The monitoring zone can be
programmed with all the standard detection enhancements
including SMART Detection
ventricular tachycardia or atrial tachyarrhythmias. Any
tachyarrhythmia meeting the Monitor Zone criteria will store an
IEGM.

TM

to monitor for non-sustained

2.5.9 Atrial Monitoring Zone

This feature allows the device to store an IEGM for atrial
tachyarrhythmias such as Atrial Fibrillation or Atrial Flutter. The
zone is programmed by rate with a range of 100 bpm to 250 bpm.
Any atrial tachyarrhythmia meeting the Atrial Arrhythmia Monitor
Zone criteria will store an IEGM.

90 Lumax Technical Manual

2.6 Tachyarrhythmia Redetection

The Lumax ICDs/CRT-Ds offer independently programmable
settings for determining if tachyarrhythmias remain after therapy
has been delivered. The redetection routine allows the
ICDs/CRT-Ds to determine whether further therapy is required
when the initial therapy was unsuccessful in terminating the
arrhythmia.

Tachyarrhythmia redetection criteria are based on cardiac cycle
length and number of intervals. The number of intervals is distinct
and independent of the initial detection criteria.

2.6.1 VT Redetection

The Counter: Redetection parameter may be programmed
separately for each arrhythmia class, independent of the initial
detection parameters:

Redetection of an ongoing tachyarrhythmia is declared when the
Counter: Redetection is satisfied (based on individual cycles). If a
sensed cardiac signal meets any VT rate criteria, following
therapy, that signal is counted and compared to the programmed
Counter: Redetection setting.

Redetection functions are based exclusively on the VT criterion.

2.6.2 SMART Redetection

DR and HF versions only

With SMART Redetection programmed ON, both atrial and
ventricular signals are used for redetection after initial detection
and therapy for a VT. SMART Detection™ will function identically
as in initial VT detection. SMART Redetection is autotmatically
programmed ON in the Lumax 600/640 and 700/740 models.

2.6.3 Forced Termination

DR and HF versions only

With SMART Redetection programmed ON, this programmed
parameter sets a time after which the SMART Redetection will be
terminated even if the SVT is still ongoing. This forces the device
to terminate the episode and allow detection of a new VT or VF
episode.