ProMRI ICD/CRT-D Post Approval Study

Completed

• Conditions: Tachyarrhythmia

• Registration Number: NCT02933619
• Lead Sponsor: Biotronik, Inc.

Brief Summary

Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24249

Inclusion Criteria

• ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.	Up to 5 years post-approval	Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.	Up to 5 years post-approval

Secondary Outcome Measures

Name	Time	Method
Left ventricular sensing attenuation	Up to 5 years post-approval	Proportion of subjects who experience left ventricular sensing amplitude attenuation \>50% between pre-MRI and 30 days post-MRI.
Workflow compliance following MR exposure	Up to 5 years post-approval	Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI.