Medtronic DDPC3D1 Clinical Study / Summary

Magnetic Resonance (MR) Conditional Tachyarrhythmia
Therapy Products Post-Approval Study

Clinical study

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physician.

Table of Contents

Table of Contents ............................................................................................................. 2

1 Summary of the Post-Approval Study Methods ............................................................. 3

1.1 Study Objective ......................................................................................................... 3

1.2 Study Design ............................................................................................................ 3

1.3 Patient Population ..................................................................................................... 3

1.4 Data Source .............................................................................................................. 3

1.5 Key Study Endpoints ................................................................................................ 3

1.5.1 Primary Objective ............................................................................................... 3

1.5.2 Additional Analyses ............................................................................................ 4

1.6 Total Number of Enrolled Study Sites and Patients, Follow- up Rate ........................ 4

1.7 Study Visits and Length of Follow-up ........................................................................ 4

2 Summary of the Post-Approval Study Results ............................................................... 4

2.1 Final Safety and Effectiveness Findings .................................................................... 4

2.2 Study Strengths and Weaknesses ............................................................................ 6

3 Conclusions................................................................................................................... 7

1 Summary of the Post-Approval Study Methods

1.1 Study Objective

As part of the requirement to satisfy the PMA Conditions of Approval, this Post-Approval
Study was conducted to assess the MR Conditional Tachyarrhythmia Therapy Systems
sensing and detection performance following MR exposure by actively monitoring de­identified device data obtained through the Medtronic CareLink

1.2 Study Design

MR Conditional Tachyarrhythmia Therapy Systems enrolled in the Medtronic CL Network
were used to assess spontaneous Ventricular Fibrillation (VF) episode detection following
MRI exposure. An MRI is considered to have been performed if the device MRI-compatible
mode (SureScan

TM

mode) has been enabled and remains in the MRI-compatible mode for
at least 20 minutes, which has been correlated with an occurrence of an MRI scan in
pacemaker patients

1

.

All post-MRI spontaneous episodes detected by the device in the VF zone were reviewed
by an Episode Review Committee (ERC). The ERC was a committee comprised of
external independent experts with applicable technical and clinical backgrounds. The ERC
classified the episodes as a true VF or PMVT, or a non-PMVT/VF episode. The arrhythmia
detection delay was also assessed by the ERC.

The study goal was to analyze the primary objective when 50 patients with a true VF
episode following MR exposure have been identified or 5 years post-approval, whichever
comes first.

1.3 Patient Population

The study population was sourced from patients from the US, Canada, Australia and New
Zealand who were implanted with an MR conditional tachyarrhythmia therapy system,
followed in the Medtronic CL network with de-identified data accessibility.

1.4 Data Source

De-identified device data were obtained through the Medtronic CL Network.

1.5 Key Study Endpoints

1.5.1 Primary Objective

 To characterize the proportion of episodes with ≥ 5 seconds VF detection delay in the

MR conditional tachyarrhythmia therapy system following MRI exposure.

TM

(CL) Network.

The primary objective analysis cohort was defined as MR conditional tachyarrhythmia
therapy system implanted patients with a true VF episode (i.e. as classified by ERC)
which occurred after the patient has experienced at least one MRI scan.

If one or no VF detection delays were identified, the primary objective is met.
If more than one (1) true VF detection delay (≥ 5 seconds) was identified, additional

1

Real-World Evaluation of Magnetic Resonance Imaging in Patients with a Magnetic Resonance
Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629
Patients. Williamson BD. et al. JACC Clin Electrophysiol. 2017 November