SureScan Post-Approval Study

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.

Research Team

Eligibility Criteria

Inclusion Criteria

Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device

Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication