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

Completed

• Conditions: Tachyarrhythmia

• Registration Number: NCT02849769
• Lead Sponsor: Medtronic

Brief Summary

Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

Detailed Description

Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Primary Completion: 2018-12
• Study Completion: 2019-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10979

Inclusion Criteria

• MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.	up to 5 years post-approval.	The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified

Secondary Outcome Measures

Name	Time	Method
The number of patients with 2 or more scans	up to 5 years post-approval	The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.
Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink	up to 5 years post-approval	Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements