Bradycardia
Conditions
Keywords
MR conditional
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.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2. 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 3. 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
1. Subject who is, or will be inaccessible for follow-up 2. Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable 3. Subject with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI Related Complication Rate | 5 years |
| Lead Related Complication Rate | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed