Last updated on May 2019

SJM Brady MRI Post Approval Study


Brief description of study

The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI, Assurity MRI, Endurity MRI pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.

Detailed Study Description

This is a prospective, multi-center clinical study designed to evaluate the long-term safety of the Tendril MRI lead implanted with any SJM Brady MRI pacemaker or similar model (SJM Brady MRI system) in subjects with a standard bradycardia pacing indication through 60 months of follow up.

Additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM Brady MRI system may be included in this evaluation if they are scheduled for or planning to have a MRI scan during the course of the study.

Note: Only the Accent MRI pacemaker has not been approved by the FDA for market release. Former IDE patients implanted with the Accent MRI pacemaker are approved to rollover into this PAS. No new implants with the Accent MRI pacemaker will be enrolled.

Clinical Study Identifier: NCT03170583

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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