Mintek LV-T, LV User Manual

Stratos

Family of Cardiac Resynchronization

Therapy Pacemakers

Technical Manual

Stratos CRT-Ps

Implantable Cardiac Resynchronization Therapy Pacemakers

Stratos

X-Ray identification

Radiopaque Identification

A radiopaque identification code is visible on standard x-ray, and
identifies the pulse generator:

Stratos LV/LV-T

SV

CAUTION

Lead / CRT-P Compatibility – Because of the numerous

available 3.2-mm configurations (e.g., the IS-1 and VS-1
standards), lead/ CRT-P compatibility should be confirmed
with the CRT-P and/or lead manufacturer prior to the
implantation of the system.

IS-1, wherever stated in this manual, refers to the
international standard, whereby leads and generators from
different manufacturers are assured a basic fit. [Reference
ISO 5841-3:1992(E)].

©2008 BIOTRONIK, Inc., all rights reserved.

Stratos LV/LV-T Technical Manual i

Contents

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

1.1 Device Description ........................................................1

1.2 Indications .....................................................................2

1.3 Contraindications ..........................................................3

1.4 Note to Physician ..........................................................3

1.5 Warnings and Precautions ............................................3

1.5.1 Interactions with Other Medical Therapy...............4

1.5.2 Storage and Sterilization .......................................6

1.5.3 Lead Connection and Evaluation ..........................7

1.5.4 Programming and Operation.................................8

1.5.5 Home Monitoring ................................................. 11

1.5.6 Electromagnetic Interference (EMI) ....................13

1.5.7 Home and Occupational Environments...............13

1.5.8 Cellular Phones ................................................... 14

1.5.9 Hospital and Medical Environments....................15

1.5.10 Device Explant and Disposal............................... 15

1.6 Potential Effects of the Device on Health.................... 16

1.7 Clinical Studies............................................................17

1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT ......17

1.7.2 Stratos LV Clinical Study – OVID study ..............39

1.7.3 AVAIL and OVID Combined Primary

Endpoint-Complication-free Rate (Safety) ..........47

1.7.4 Tupos LV/ATx Clinical IDE Study -

OPTION CRT/ATx...............................................49

1.7.5 Conclusions Drawn from Studies ........................ 61

2. Programmable Parameters............................................63

2.1 Pacing Modes..............................................................63

2.1.1 Rate-adaptive Modes ..........................................63

2.1.2 DDD.....................................................................63

2.1.3 DDI ......................................................................67

2.1.4 DVI....................................................................... 67

2.1.5 VDD ..................................................................... 67

2.1.6 AAI and VVI .........................................................68

2.1.7 AAI, VVI ............................................................... 68

2.1.8 AOO, VOO...........................................................68

2.1.9 DOO ....................................................................68

2.1.10 VDI.......................................................................68

ii Stratos LV/LV-T Technical Manual

2.1.11 OFF (ODO) ..........................................................69

2.2 Biventricular Synchronization of the Stratos CRT-Ps..69

2.3 Timing Functions .........................................................70

2.3.1 Basic Rate ...........................................................70

2.3.2 Rate Hysteresis ...................................................71

2.3.3 Scan Hysteresis...................................................72

2.3.4 Repetitive Hysteresis...........................................74

2.3.5 Night Mode ..........................................................75

2.3.6 Refractory Periods...............................................76

2.3.7 Atrial PMT Protection...........................................77

2.3.8 Ventricular Refractory Period ..............................78

2.3.9 AV Delay..............................................................78

2.3.10 VES Discrimination after Atrial Sensed Events ...80

2.3.11 Sense Compensation ..........................................80

2.3.12 Ventricular Blanking Period .................................81

2.3.13 Safety AV Delay ..................................................81

2.4 Pacing and Sensing Functions....................................82

2.4.1 Pulse Amplitude and Pulse Width .......................82

2.4.2 Sensitivity ............................................................83

2.4.3 Lead Polarity........................................................83

2.5 Automatic Lead Check ................................................84

2.6 Antitachycardia Functions: ..........................................86

2.6.1 Upper Rate and UTR Response .........................86

2.7 Wenckebach 2:1..........................................................86

2.8 Mode Switching ...........................................................88

2.9 PMT Management....................................................... 89

2.9.1 Protection ............................................................89

2.9.2 PMT Detection.....................................................90

2.10 Adjustment of the PMT Protection Window.................91

2.11 Atrial Upper Rate.........................................................92

2.12 Preventive Overdrive Pacing (Overdrive Mode) .........92

2.13 AES Detection and Pacing..........................................94

2.13.1 AES Detection .....................................................94

2.13.2 Post AES Stimulation ..........................................95

2.14 Parameters for Rate-Adaptive Pacing ........................95

2.14.1 Rate-Adaptation...................................................95

2.14.2 Sensor Gain.........................................................96

2.14.3 Automatic Sensor Gain .......................................96

2.14.4 Sensor Threshold ................................................97

2.14.5 Rate Increase ......................................................97

Stratos LV/LV-T Technical Manual iii

2.14.6 Maximum Activity Rate ........................................ 98

2.14.7 Rate Decay ..........................................................98

2.15 Sensor Stimulation ......................................................98

2.16 Rate Fading................................................................. 99

2.17 Home Monitoring (Stratos LV-T)................................100

2.17.1 Transmission of Information ..............................102

2.17.2 Patient Device ...................................................103

2.17.3 Transmitting Data ..............................................103

2.17.4 Types of Report Transmissions ........................105

2.17.5 Description of Transmitted Data........................107

2.18 Statistics ....................................................................109

2.18.1 Timing ................................................................109

2.18.2 Arrhythmia .........................................................109

2.18.3 Sensor ...............................................................109

2.18.4 Sensing..............................................................109

2.18.5 Pacing................................................................109

2.18.6 General Statistical Information ..........................110

2.19 Interrogating and/or Starting Statistics ......................110

2.20 Timing Statistics ........................................................ 111

2.20.1 Event Counter.................................................... 111

2.20.2 Event Episodes.................................................. 111

2.20.3 Rate Trend.........................................................112

2.20.4 Atrial and Ventricular Rate Histogram ...............112

2.21 Arrhythmia Statistics.................................................. 113

2.21.1 Tachy Episode Trend ........................................113

2.21.2 AF Classification................................................113

2.21.3 AES Statistics ....................................................114

2.21.4 VES Statistics ....................................................115

2.22 Sensor Statistics........................................................ 116

2.22.1 Sensor Rate Histogram .....................................116

2.22.2 Activity Report ...................................................117

2.22.3 Sensor Optimization ..........................................117

2.23 Sensing Statistics ...................................................... 117

2.24 Pacing Statistics ........................................................ 118

3. Follow-up Procedures.................................................. 119

3.1 General Considerations ............................................119

4. Real-Time IEGM ............................................................121

4.1 IEGM Recordings......................................................121

iv Stratos LV/LV-T Technical Manual

5. Battery, Pulse and Lead Data ......................................123

5.1 Threshold Test - Testing the Pacing Function ...........123

5.2 P/R Measurement - Testing the Sensing Function....124

5.3 Testing for Retrograde Conduction ...........................125

5.4 Non-Invasive Programmed Stimulation (NIPS).........125

5.4.1 Description.........................................................125

5.4.2 Burst Stimulation ...............................................126

5.4.3 Programmed Stimulation...................................126

5.4.4 Back up Pacing..................................................126

5.4.5 NIPS Safety Features........................................127

6. Other Functions/Features............................................129

6.1 Temporary Programming...........................................129

6.2 Patient Data Memory.................................................130

6.3 Safe Program Settings ..............................................130

6.4 Magnet Effect ............................................................131

6.5 Position Indicator.......................................................131

6.6 Pacing When Exposed to Interference .....................132

7. Product Storage and Handling....................................135

7.1 Sterilization and Storage ...........................................135

7.2 Opening the Sterile Container...................................136

7.3 Pulse Generator Orientation .....................................138

8. Lead Connection ..........................................................139

8.1 Lead Configuration....................................................139

8.2 Lead Connection .......................................................140

9. Elective Replacement Indication (ERI).......................145

10. Explantation ..................................................................149

11. Technical Data...............................................................151

11.1 Available Pacing Modes............................................151

11.2 Pulse- and Control Parameters................................. 151

11.3 Diagnostic Memory Functions...................................156

11.4 Home Monitoring (Stratos LV-T)................................156

11.5 Additional Functions..................................................157

11.6 Programmers.............................................................158

11.7 Default Programs ......................................................159

11.8 Materials in Contact with Human Tissue...................159

11.9 Electrical Data/Battery...............................................159

11.10 Mechanical Data ..................................................160

Stratos LV/LV-T Technical Manual v

12. Order Information.........................................................161

Appendix A ..........................................................................163

vi Stratos LV/LV-T Technical Manual Stratos LV/LV-T Technical Manual 1

1. General

1.1 Device Description

The Stratos LV and Stratos LV-T CRT-Ps are rate adaptive
pacemakers designed to provide Cardiac Resynchronization
Therapy (CRT). The Stratos CRT-Ps provide all standard
bradycardia pacemaker therapy with the additional capabilities of
biventricular pacing for CRT. Biventricular pacing in the
Stratos CRT-Ps can be programmed to initially pace in either the
right or left ventricular chambers with separately programmable
outputs for both left and right channels. Sensing of cardiac
signals only occurs in the right ventricular chamber.

The Stratos CRT-Ps can also provide single and dual chamber
pacing in a variety of rate-adaptive and non-rate adaptive pacing
modes. Pacing capability is supported by an extensive
diagnostic set. For motion-based rate-adaptation, the
Stratos CRT-Ps are equipped with an internal accelerometer.
This sensor produces an electric signal during physical activity of
the patient. If a rate-adaptive (R) mode is programmed, then the
accelerometer sensor signal controls the stimulation rate.

The Stratos LV-T additionally also employs BIOTRONIK’s Home
Monitoring™ technology, which is an automatic, wireless, remote
monitoring system for management of patients with implantable
devices. With Home Monitoring, physicians can review data
about the patient’s cardiac status and CRT-P’s functionality
between regular follow-up visits, allowing the physician to
optimize the therapy process. Stratos CRT-Ps are also
designed to collect diagnostic data to aid the physician’s
assessment of a patient’s condition and the performance of the
implanted device.

The bipolar IS-1 connections are used for pacing and sensing
(right atrial and ventricle) and the additional IS-1 connection is
used for pacing in the left ventricle in either a bipolar or unipolar
configuration depending on the left ventricular lead. The pulse
amplitude and pulse width of each of the three channels is
separately programmable.

2 Stratos LV/LV-T Technical Manual

Stratos CRT-Ps are designed to meet all indications for Cardiac
Resynchronization Therapy in CHF patients as well as those for
bradycardia therapy as exhibited in a wide variety of patients.
The Stratos family is comprised of two CRT-Ps that are designed
to handle a multitude of situations.

Stratos LV

Stratos LV-T

Throughout this manual, specific feature and function
descriptions may only be applicable to the Stratos LV-T and
those features will be referenced as such. Otherwise, reference
to Stratos CRT-Ps refers to both devices.

Triple chamber, rate-adaptive,
unipolar/bipolar pacing CRT-P

Triple chamber, rate-adaptive,
unipolar/bipolar pacing CRT-P with Home
Monitoring

1.2 Indications

The Stratos LV and Stratos LV-T Cardiac Resynchronization
Therapy Pacemakers (CRT-Ps) are indicated for patients who
have moderate to severe heart failure (NYHA Class III/IV),
including left ventricular dysfunction (EF ≤ 35%) and
QRS ≥ 120 ms and remain symptomatic despite stable, optimal
heart failure drug therapy.

Stratos LV/LV-T Technical Manual 3

1.3 Contraindications

Use of Stratos LV and Stratos LV-T CRT-Ps are contraindicated
for the following patients:

• Unipolar pacing is contraindicated for patients with an

implanted cardioverter-defibrillator (ICD) because it may
cause unwanted delivery or inhibition of ICD therapy.

• Single chamber atrial pacing is contraindicated for

patients with impaired AV nodal conduction.

• Dual chamber and single chamber atrial pacing is

contraindicated for patients with chronic refractory atrial
tachyarrhythmias.

1.4 Note to Physician

As with any implantable pulse generator, there are certain
infrequent risks associated with Stratos CRT-Ps. Section 1.6
lists the adverse events that have been observed or may
potentially occur with these Cardiac Resynchronization Therapy
Pacemakers. The warnings and precautions listed in
Section 1.5 should be taken under serious consideration in order
to aid in avoiding device failures and harm to the patient.

Regular monitoring of the patient and their implanted device
should be conducted to identify performance concerns and
ensure appropriate therapy is being administered to the patient.
Please communicate any performance concerns to BIOTRONIK
and to FDA.

All explanted devices should be returned to the manufacturer for
testing to help understand device reliability and performance.
Refer to Section 10 for recommended procedures for handling
explanted devices.

1.5 Warnings and Precautions

Certain therapeutic and diagnostic procedures may cause
undetected damage to a Cardiac Resynchronization Therapy
Pacemakers, resulting in malfunction or failure at a later time.
Please note the following warnings and precautions:

4 Stratos LV/LV-T Technical Manual

Magnetic Resonance Imaging (MRI) – Avoid use of magnetic
resonance imaging as it has been shown to cause movement of
the CRT-Ps within the subcutaneous pocket and may cause pain
and injury to the patient and damage to the CRT-P. If the
procedure must be used, constant monitoring is recommended,
including monitoring the peripheral pulse.

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

NIPS – Life threatening ventricular arrhythmias can be induced
by stimulation in the ventricle. Ensure that an external cardiac
defibrillator is accessible during tachycardia testing. Only
physicians trained and experienced in tachycardia induction and
reversion protocols should use non-invasive programmed
stimulation (NIPS).

High Output Settings – High output settings combined with
extremely low lead impedance may reduce the life expectancy of
the Stratos CRT-Ps. Programming of pulse amplitudes, higher
than 4.8 V, in combination with long pulse widths and/or high
pacing rates may lead to premature activation of the
replacement indicator.

1.5.1 Interactions with Other Medical Therapy

Before applying one of the following procedures, a detailed
analysis of the advantages and risks should be made. Cardiac
activity during one of these procedures should be confirmed by
continuous monitoring of peripheral pulse or blood pressure.
Following the procedures, CRT-P function and stimulation
threshold must be checked.

Therapeutic Diathermy Equipment – Use of therapeutic
diathermy equipment is to be avoided for pacemaker patients
due to possible heating effects of the CRT-P and at the implant
site. If diathermy therapy must be used, it should not be applied
in the immediate vicinity of the CRT-P or leads. The patient's
peripheral pulse should be monitored continuously during the
treatment.

Stratos LV/LV-T Technical Manual 5

Transcutaneous Electrical Nerve Stimulation (TENS) –

Transcutaneous electrical nerve stimulation may interfere with
CRT-P function. If necessary, the following measures may
reduce the possibility of interference:

• Place the TENS electrodes as close to each other as

possible.

• Place the TENS electrodes as far from the CRT-P/lead

system as possible.

• Monitor cardiac activity during TENS use.

Defibrillation – The following precautions are recommended to
minimize the inherent risk of CRT-P operation being adversely
affected by defibrillation:

• The paddles should be placed anterior-posterior or along

a line perpendicular to the axis formed by the CRT-P
and the implanted lead.

• The energy setting should not be higher than required to

achieve defibrillation.

• The distance between the paddles and the CRT-P/leads

should not be less than 10 cm (4 inches).

Radiation – The CRT-P’s internal electronics may be damaged
by exposure to radiation during radiotherapy. To minimize this
risk when using such therapy, the CRT-P should be protected
with local radiation shielding.

Lithotripsy – Lithotripsy treatment should be avoided for CRT-P
patients since electrical and/or mechanical interference with the
CRT-P is possible. If this procedure must be used, the greatest
possible distance from the point of electrical and mechanical
strain should be chosen in order to minimize a potential
interference with the CRT-P.

Electrocautery – Electrocautery should never be performed
within 15 cm (6 inches) of an implanted CRT-P or leads because
of the danger of introducing fibrillatory currents into the heart
and/or damaging the CRT-P. Pacing should be asynchronous
and above the patient’s intrinsic rate to prevent inhibition by
interference signals generated by the cautery. When possible, a
bipolar electrocautery system should be used.

6 Stratos LV/LV-T Technical Manual

For transurethral resection of the prostate, it is recommended
that the cautery ground plate be placed under the buttocks or
around the thigh, but not in the thoracic area where the current
pathway could pass through or near the CRT-P system.

1.5.2 Storage and Sterilization

Storage (temperature) – Recommended storage temperature

range is 5° to 55°C (41°-131°F). Exposure to temperatures
outside this range may result in CRT-P malfunction (see
Section 7.1).

Low Temperatures – Exposure to low temperatures (below
0°C) may cause a false elective replacement indication to be
present. If this occurs, warm the device to room temperature
and reset the ERI with magnet application (see Section 7.1).

Handling – Do not drop. If an unpackaged CRT-P is dropped
onto a hard surface, return it to BIOTRONIK (see Section 7.1).

FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or
accessories packaged with the CRT-P, they are intended for
one-time use.

Device Packaging – Do not use the device if the packaging is
wet, punctured, opened or damaged because the integrity of the
sterile packaging may be compromised. Return the device to
BIOTRONIK.

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

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

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

Stratos LV/LV-T Technical Manual 7

1.5.3 Lead Connection and Evaluation

Lead Check –

Feature Description

: Lead Check is a feature that, when
activated, automatically measures the lead impedance with
every pace. Based on these measurements, the lead
configuration will be set to either unipolar or bipolar. Refer to
Section 2.5 for more details regarding this feature.

Caution

: Lead check will not lead to disabling of cardiac
resynchronization therapy. It limits the use of the
resynchronization features.

1. Lead check is possible only when the right ventricle is
paced first.

2. Lead check works only when the pacing voltages are
programmed between 2.4 and 4.8 V. The lead check
feature can be programmed OFF in patients that require
cardiac resynchronization therapy.

Care should be taken when programming Stratos CRT-Ps with
Lead Check ON as the device may switch from bipolar to
unipolar pacing and sensing without warning. This situation may
be inappropriate when using a Stratos CRT-P for patients with
an Implantable Cardioverter Defibrillator (ICD). The following
associated message appears when programming this feature:

“Lead check may result in a switch to unipolar pacing and
sensing, which may be inappropriate for patients with an
ICD.”

Additionally, Lead Check should be programmed OFF before
lead connection as the feature will automatically reprogram the
device to unipolar in the absence of a lead.

Lead / CRT-P Compatibility – Because of the numerous
available 3.2-mm configurations (e.g., the IS-1 and VS-1
standards), lead/ CRT-P compatibility should be confirmed with
the CRT-P and/or lead manufacturer prior to the implantation of
the system.

8 Stratos LV/LV-T Technical Manual

IS-1, wherever stated in this manual, refers to the international
standard, whereby leads and generators from different
manufacturers are assured a basic fit. [Reference ISO 5841­3:1992(E)].

Lead Configuration – The polarity of the implanted lead
dictates what lead configuration can be programmed for the
CRT-P. Pacing will not occur with a unipolar lead if the lead
configuration of the respective channel is programmed to bipolar
(see Section 8).

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 overtighten the setscrew(s).
Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque
wrench into the perforation at an angle perpendicular to the

connector receptacle. Failure to do so may result in damage to
the plug and its self-sealing properties.

1.5.4 Programming and Operation

IEGM – Due to the compression processes that the signals

undergo, the IEGM recordings are not suitable for making some
specific cardiac diagnoses, such as ischemia; although, these
tracings may be useful in diagnosing arrhythmias, device
behavior or programming issues.

Post AES - Before activating post-AES, check whether the
selected program can cause Pacemaker Mediated Tachycardia
(PMT) and whether post-AES pacing results.

Overdrive Pacing Mode - When programming the overdrive
pacing mode, check whether the selected program can cause
PMT, and whether atrial over drive pacing would result.
Corresponding to the measured retrograde conduction time, the
PMT protection interval must be programmed to a correct value.

Stratos LV/LV-T Technical Manual 9

AV Hysteresis – If the AV hysteresis is enabled along with the
algorithm for recognizing and terminating PMTs (PMT
management), the AV delay for recognizing and terminating a
PMT has a higher priority than the AV hysteresis.

Sensing – The Stratos CRT-Ps do not sense in the left ventricle.

AV Conduction – In patients with intact AV conduction, the

intrinsic atrial tachycardia is conducted to the ventricle 1:1. With
the resynchronization mode activated, spontaneous rate of the
right ventricle mode is synchronized for a rate up to 200 ppm in
the left ventricle. For this reason, biventricular pacing mode
should be turned OFF in such cases.

Unipolar/Bipolar – If the pacing or sensing function is to be
programmed to bipolar in the atrial channel, it must be verified
that bipolar leads have been implanted in that chamber. If the
atrial lead is unipolar, unipolar sensing and pacing functions
must be programmed in that chamber. Failure to program the
appropriate lead configuration could result in patient
experiencing entrance and/or exit block.

In addition, if the atrial lead polarity setting within the Patient
Data Memory has been set to bipolar, the polarity of the
corresponding implanted lead must be confirmed to be bipolar.

Safe Program – Activating the “Safe Program” is a way of
quickly programming the device to multiple settings in the event
of an emergency. These settings include unipolar pacing with
pacing output OFF in the left ventricular channel. Refer to
Section 6.3 for further details.

Programmers – Use only BIOTRONIK’s ICS 3000 programmer
equipped with appropriate software to program Stratos CRT-Ps.
Do not use programmers from other manufacturers.

Pulse Amplitude – Programming of pulse amplitudes, higher
than 4.8 V, in combination with long pulse widths and/or high
pacing rates can lead to premature activation of the replacement
indicator. If a pulse amplitude of 7.2 V or higher is programmed
and high pacing rates are reached, output amplitudes may differ
from programmed values.

10 Stratos LV/LV-T Technical Manual

Pacing thresholds – When decreasing programmed output
(pulse amplitude and/or pulse width), the pacing threshold must
first be accurately assessed to provide a 2:1 safety margin.

EMI – Computerized systems are subject to (Electromagnetic
Interference (EMI) or “noise”. In the presence of such
interference, telemetry communication may be interrupted and
prevent programming of the Stratos CRT-P.

Programming Modifications – Extreme programming changes
should only be made after careful clinical assessment. Clinical
judgment should be used when programming permanent pacing
rates below 40 ppm or above 100 ppm.

Short Pacing Intervals – Use of short pacing intervals (high
pacing rates) with long atrial and/or ventricular refractory periods
may result in intermittent asynchronous pacing and, therefore,
may be contraindicated in some patients.

OFF Mode – The OFF mode can be transmitted as a temporary
program only to permit evaluation of the patient’s spontaneous
rhythm. (see Section 2.1.11)

Myopotential Sensing – The filter characteristics of
BIOTRONIK implantable devices have been optimized to sense
electrical potentials generated by cardiac activity and to reduce
the possibility of sensing skeletal myopotentials. However, the
risk of CRT-P’s operation being affected by myopotentials
cannot be eliminated, particularly in unipolar systems.
Myopotentials may resemble cardiac activity, resulting in
inhibition of pacing, triggering and/or emission of asynchronous
pacing pulses, depending on the pacing mode and the
interference pattern. Certain follow-up procedures, such as
monitoring CRT-P performance while the patient is doing
exercises involving the use of pectoral muscles, as well as Holter
monitoring, have been recommended to check for interference
caused by myopotentials. If sensing of myopotentials is
encountered, corrective actions may include selection of a
different pacing mode or sensitivity setting.

Muscle or Nerve Stimulation – Inappropriate muscle or nerve
stimulation may occur with unipolar pacing when using a non­coated Stratos CRT-P.

Stratos LV/LV-T Technical Manual 11

Atrial Sensitivity – In dual chamber systems, the atrial
sensitivity of 0.1 mV should only be programmed in conjunction
with a bipolar lead configuration.

Programmed to Triggered Modes – When programmed to
triggered modes, pacing rates up to the programmed upper limit
may occur in the presence of either muscle or external
interference.

Triggered Modes – While the triggered modes (DDT, DVT,
DDTR/A, DDTR/V, DDI/T, VDT, VVT, and AAT) can be
programmed permanently, these modes are intended for use as
temporary programming for diagnostic purposes. In triggered
pacing modes, pacing pulses are emitted in response to sensed
signals, and therefore the pacing pulse can be used as an
indicator, or marker of sensed events for evaluating the sensing
function of the pulse generator using surface ECG. However,
real-time telemetry of marker channels and/or intracardiac
electrogram via the programmer and programming wand is
recommended over the use of a triggered pacing mode in the
clinical setting. A triggered pacing mode may be preferred in
situations where positioning the programming head over the
pulse generator would be impossible or impractical (i.e., during
exercise testing or extended Holter monitoring).

Another possible application of triggered modes is to ensure
pacing as a short term solution during a period of inhibition of
pacing by extracardiac interference, mechanical noise signals, or
other sensing abnormalities. Because triggered modes emit
pacing pulses in response to sensed events, this may result in
unnecessary pacing during the absolute refractory period of the
myocardium, inappropriate pacing in response to oversensing of
cardiac or extracardiac signals. The risks associated with
triggered pacing include excessive pacing, arrhythmias due to
the R-on-T phenomenon, and early battery depletion. Therefore,
it is important that the triggered modes are not used for long
term therapy, and that the CRT-P is always returned to a non­triggered permanent program.

1.5.5 Home Monitoring

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.

12 Stratos LV/LV-T Technical Manual

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.

Electromagnetic Interference (EMI) – Precautions for EMI
interference with the Stratos CRT-Ps are provided in
Section 1.5.6. Sources of EMI including cellular telephones,
electronic article surveillance systems, and others are discussed
therein.

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).

Event Triggered Report - A timely receipt of the event report
cannot be guaranteed. The receipt is also dependent on
whether the patient was physically situated in the required
coverage range of the patient device at the time the event
information was sent.

Patient-Activated Report - The magnet effect must be
programmed “synchronous” if the [Patient Report] function is
activated.

Not for Conclusive Diagnosis - Because not all information
available in the implant is being transmitted, the data transmitted
by Home Monitoring should be evaluated in conjunction with
other clinical indicators (i.e., in-office follow-up, patient
symptoms, etc.) in order to make a proper diagnosis.

Frequency of Office Follow-Ups When Using Home
Monitoring - The use of Home Monitoring does not replace

regular follow-up examinations. When using Home Monitoring,
the time period between follow-up visits may not be extended.

Stratos LV/LV-T Technical Manual 13

1.5.6 Electromagnetic Interference (EMI)

The operation of any implanted device may be affected by
certain environmental sources generating signals that resemble
cardiac activity. This may result in inhibition of pacing and/or
triggering or in asynchronous pacing depending on the pacing
mode and the interference pattern. In some cases (i.e.,
diagnostic or therapeutic medical procedures), the interference
sources may couple sufficient energy into a pacing system to
damage the device and/or cardiac tissue adjacent to the leads.

BIOTRONIK CRT-Ps have been designed to significantly reduce
susceptibility to electromagnetic interference (EMI). However,
due to the variety and complexity of sources creating
interference, there is no absolute protection against EMI.
Generally, it is assumed that EMI produces only minor effects, if
any, in CRT-P patients. If the patient may be exposed to one of
the following environmental conditions, then the patient should
be given the appropriate warnings.

1.5.7 Home and Occupational Environments

The following equipment (and similar devices) may affect normal
CRT-P operation: electric arc welders, electric melting furnaces,
radio/television and radar transmitters, power-generating
facilities, high-voltage transmission lines, electrical ignition
systems (also of gasoline-powered devices) if protective hoods,
shrouds, etc., are removed, electrical tools, anti-theft devices at
retail stores and electrical appliances, if not in proper condition
or not correctly grounded and encased.

Patients should exercise reasonable caution in avoidance of
devices which generate a strong electric or magnetic field. If
EMI inhibits pacing or causes a reversion to asynchronous
pacing or pacing at magnet rate, moving away from the source
or turning it off should allow the CRT-P to return to its normal
mode of operation. Some potential EMI sources include:

High Voltage Power Transmission Lines – High voltage power
transmission lines may generate enough EMI to interfere with
CRT-P operation if approached too closely.

14 Stratos LV/LV-T Technical Manual

Home Appliances – Home appliances normally do not affect
CRT-P operation if the appliances are in proper condition and
correctly grounded and encased. There are reports of CRT-P
disturbances caused by electrical tools and by electric razors
that have touched the skin directly over the CRT-P.

Communication Equipment – Communication equipment such
as microwave transmitters, linear power amplifiers, or high­power amateur transmitters may generate enough EMI to
interfere with CRT-P operation if approached too closely.

Commercial Electrical Equipment – Commercial electrical
equipment such as arc welders, induction furnaces, or
resistance welders may generate enough EMI to interfere with
CRT-P operation if approached too closely.

Electrical Appliances – Electric hand-tools and electric razors
(used over the skin directly above the CRT-P) have been
reported to cause pacemaker disturbances. Home appliances
that are in good working order and properly grounded do not
usually produce enough EMI to interfere with implanted device
operation.

Electronic Article Surveillance (EAS) – Equipment such as
retail theft prevention systems may interact with the CRT-Ps.
Patients should be advised to walk directly through and not to
remain near an EAS system longer than necessary.

Radio-Frequency Identification (RFID) – RFID tags may
interact with the CRT-Ps. Patients should be advised to avoid
leaving a device containing such a tag within close proximity to
the CRT-P (i.e., inside a shirt pocket).

1.5.8 Cellular Phones

Recent studies have indicated there may be a potential
interaction between cellular phones and pacemaker operation.
Potential effects may be due to either the radio frequency signal
or the magnet within the phone and could include inhibition or
asynchronous pacing when the phone is within close proximity
(within 6 inches [15 cm]) to the CRT-P.

Stratos LV/LV-T Technical Manual 15

Based on testing to date, effects resulting from an interaction
between cellular phones and the implanted pacemakers have
been temporary. Simply moving the phone away from the
implanted device will return it to its previous state of operation.
Because of the great variety of cellular phones and the wide
variance in patient physiology, an absolute recommendation to
cover all patients cannot be made.

Patients having an implanted CRT-P who operate a cellular
phone should:

• Maintain a minimum separation of 6 inches (15 cm)
between a hand-held personal cellular phone and the
implanted device. Portable and mobile cellular phones
generally transmit at higher power levels compared to
hand held models. For phones transmitting above
3 watts, maintain a minimum separation of 12 inches
(30 cm) between the antenna and the implanted device.

• Patients should hold the phone to the ear opposite the
side of the implanted device. Patients should not carry
the phone in a breast pocket or on a belt over or within
6 inches (15 cm) of the implanted device as some
phones emit signals when they are turned ON but not in
use (i.e., in the listen or standby mode). Store the
phone in a location opposite the side of implant.

1.5.9 Hospital and Medical Environments

Refer to Section 1.5.1 for information regarding CRT-P
interaction with the following medical procedures / environments:

• Electrosurgical Cautery

• Lithotripsy

• External Defibrillation

• High Radiation Sources

1.5.10 Device Explant and Disposal

Device Incineration - Never incinerate a CRT-P. Be sure the

CRT-P is explanted before a patient who has died is cremated.
(see Section 10)

Explanted Devices – Return all explanted devices to
BIOTRONIK.

16 Stratos LV/LV-T Technical Manual

1.6 Potential Effects of the Device on
Health

The following possible adverse events may occur with this type
of CRT-P based on implant experience including:

Potential Adverse Events

• Air embolism

• Allergic reactions to

contrast media

• Arrhythmias

• Bleeding

• Body rejection

phenomena

• Cardiac tamponade

• Chronic nerve damage

• Damage to heart valves

• Elevated pacing

thresholds

• Extrusion

• Fluid accumulation

• 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

• Hematoma

• Device migration

• Thromboembolism

• Undersensing of

intrinsic signals

• Venous occlusion

• Venous or cardiac

perforation

Stratos LV/LV-T Technical Manual 17

1.7 Clinical Studies

The subsequent sections summarize the following three clinical
studies that were used to support the safety and effectiveness of
the Stratos LV/LV-T CRT-Ps.

• The AVAIL CLS/CRT clinical study

• The OVID clinical study (OUS)

• The OPTION CRT/ATx clinical study

Two of the studies, AVAIL CLS/CRT and OVID, collected
significant safety data supporting use of the Stratos LV/LV-T
CRT-P system. The third study, OPTION CRT/ATx, supports
the effectiveness of cardiac resynchronization therapy (CRT).
The OPTION CRT/ATx study was conducted on a device that
delivers CRT but, in addition, also offers defibrillation therapy
(CRT-D).

1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT

Study Design

The AVAIL CLS/CRT was a multi-center, prospective,
randomized, blinded clinical study designed to support approval
for cardiac resynchronization therapy for a Heart Failure (HF)
patient population not requiring back up defibrillation and that are
indicated for an ablate and pace procedures. All patients
enrolled into the clinical study were randomly assigned to one of
three groups using a 2:2:1 ratio for randomization.

18 Stratos LV/LV-T Technical Manual

• Patients assigned to Group 1 received biventricular
pacing with CLS-based rate adaptive pacing using
BIOTRONIK’s Protos DR/CLS, which is a dual-chamber
pulse generator with CLS-based rate adaptive pacing.
During this study, the Protos DR/CLS devices were
implanted with two ventricular leads: the right ventricular
lead was connected to the ventricular port, and the left
ventricular lead was connected to the atrial port. Protos
DR/CLS was included in this study to evaluate
biventricular pacing with a different type of rate adaptive
sensor technology.

• Patients assigned to Group 2 received biventricular
pacing with accelerometer-based rate adaptive pacing
using the Stratos LV.

• Patients assigned to Group 3 (control group) received
right ventricular pacing with accelerometer-based rate
adaptive pacing using the Stratos LV. Therefore, 60% of
the patients received a Stratos LV device.

Primarily, the study evaluated and compared the functional
benefits of CRT between the three 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 (prior to implant and ablation) and again
at a six-month follow-up evaluation. The data collected during
this clinical study was used to demonstrate superiority of CRT to
RV only pacing. This study also evaluated the safety of both the
Protos DR/CLS and Stratos LV devices through an analysis of
the complication-free rate through six months. Secondarily, the
study also evaluated the superiority of CRT with CLS rate
adaptation compared to CRT with accelerometer rate adaptation.

Stratos LV/LV-T Technical Manual 19

Clinical Inclusion Criteria

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

• Meet the indications for therapy

• Persistent (documented for more than 7 days),

symptomatic AF with poorly controlled rapid ventricular
rates or permanent, (documented for more than 30 days
with failed cardioversion, or longstanding AF of 6 months
or more) symptomatic AF with poorly controlled rapid
ventricular rates.

• Eligible for AV nodal ablation and permanent pacemaker
implantation

• NYHA Class II or III heart failure

• Age ≥ 18 years

• Understand the nature of the procedure

• Ability to tolerate the surgical procedure required for

implantation

• Give informed consent

• Able to complete all testing required by the clinical

protocol

• Available for follow-up visits on a regular basis at the
investigational site

20 Stratos LV/LV-T Technical Manual

Clinical Exclusion Criteria

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

• Meet one or more of the contraindications

• Have a life expectancy of less than six months

• Expected to receive heart transplantation within six

months

• Enrolled in another cardiovascular or pharmacological
clinical investigation

• Patients with an ICD, or being considered for an ICD

• Patients with previously implanted biventricular pacing

systems

• Patients with previously implanted single or dual
chamber pacing system with > 50% documented
ventricular pacing

• Patients with previous AV node ablation

• Six-minute walk test distance greater than 450 meters

• Any condition preventing the patient from being able to

perform required testing

• Presence of another life-threatening, underlying illness
separate from their cardiac disorder

• Conditions that prohibit placement of any of the lead
systems

Follow-Up Schedule

At the enrollment screening, the physician evaluated the patient
to verify that all inclusion/exclusion criteria have been met in
accordance to the protocol and the patient has signed the
informed consent. After successful enrollment, all patients were
implanted with either a Stratos LV CRT-P or Protos DR/CLS
device. Evaluations at the Four Week, Three and Six Month
follow-ups included NYHA classification, medications, and
percentage of ventricular pacing.

Clinical Endpoints

Stratos LV/LV-T Technical Manual 21

Primary Endpoint: Complication-free Rate (Safety)
The safety of the Stratos LV was evaluated based on
complications (adverse events that require additional invasive
intervention to resolve) related to the implanted CRT system
which includes the Stratos LV, the right ventricular, the left
ventricular lead, lead ventricular lead adapters (if used) and the
implant procedure. The target complication-free rate at six
months is 85%.

Primary Endpoint: Six Minute Walk Test & QOL (Effectiveness)
The purpose of Primary Endpoint 1 was to evaluate the
effectiveness of the CRT (Groups 1 and 2) compared to RV only
(Group 3) pacing as measured by the average composite rate of
improvement in six minute walk test and QOL.

Accountability of PMA Cohorts

After randomization and enrollment, 23 patients (8 in Group 1, 8
in Group 2 and 7 in Group 3) did not receive an implant. The
reasons for patients not receiving an implant are outlined in

Figure 1

. Two additional patients in Group 1 had an
unsuccessful first implant attempt (unable to implant the LV
lead), but follow up data was not received.

22 Stratos LV/LV-T Technical Manual

Enrolled and Randomized Patients

Group 1 43
Group 2 50
Group 3 25

Implant Attempted

Group 1 39
Group 2 44
Group 3 21

Successful implant

Group 1 33
Group 2 42
Group 3 18

Completed 6-Month Follow-up

Group 1 23
Group 2 30
Group 3 15

No im pla nt Atte mpte d

Withdrawal of Consent

Not Meeting Inclusion Criteria

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Follow-up to failed implant data pending

Ablation/Abla tion Data Pending

6-Month Fol low-up Da ta

Patient Death before 6-Month

Withdrew before 6-Month FU

Not Reached 6-Month FU or Data Pending

6-month FU Not Completed

Figure 1: Patient Accountability

Demographics and Baseline Parameters

Group 1 2
Group 2 4
Group 3 3

Group 1 2
Group 2 2
Group 3 1

Group 1 4
Group 2 2
Group 3 3

Group 1 2
Group 2 0
Group 3 0

Group 1 3
Group 2 0
Group 3 0

Group 1 0
Group 2 2
Group 3 0

Group 1 1
Group 2 1
Group 3 0

Group 1 6
Group 2 8
Group 3 3

Group 1 0
Group 2 1
Group 3 0

Table 1

provides a summary of the patient demographics at
enrollment. There were no statistical differences in enrollment
demographics between the 3 groups.