SureScan Post-Approval Study

Medtronic

Status: Completed

Conditions: Bradycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT01299675

SureScan PAS

Details and patient eligibility

About

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.

Enrollment: 2,483 patients

Sex: All

Volunteers: No Healthy Volunteers

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 exclusion criteria required by local law

Trial design

2,483 participants in 2 patient groups

Chronic Performance

Description:

Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.

Multiple MRI Scan Characterization

Description:

Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care.