NCT03170583

SJM Brady MRI Post Approval Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,768 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	St. Jude Medical Tendril MRI™ lead	pacemaker, leads

Timeline

• Start date: 2017-06-08
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2017-05-31
• Last updated: 2020-07-28

Locations

66 sites across 1 country: United States

Regulatory

• FDA-regulated device study