SureScan Post-Approval Study

Sponsored by Medtronic Cardiac Rhythm Disease Management

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. This study is part of the Product Performance Platform (PPP).

Condition

Bradycardia

 

Groups/Chohorts

Chronic Performance Arm 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 Arm Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic's standard of care.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population
Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

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

Contacts and Locations

Contacts
Physicians:
Ameer Kabour, MD

Coordinators:
Brenda Hoagland, RN, CCRC
Michelle Hickam, BSN
Julie Neidhardt, BSN

Please contact us at 419-251-4919 for more information about this study.