SureScan Post-Approval Study
Completed
- Conditions
- Bradycardia
- Registration Number
- NCT01299675
- Lead Sponsor
- Medtronic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2483
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
Exclusion Criteria
- Subject who is, or will be inaccessible for follow-up
- Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
- Subject with exclusion criteria required by local law
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI Related Complication Rate 5 years Lead Related Complication Rate 5 years
- Secondary Outcome Measures
Name Time Method Assess change in pacing thresholds after multiple MRI scans 5 years Summarize MRI system and scan conditions 5 years Pacing system related events 5 years Characterize lead impedance 5 years