SureScan Post-Approval Study

Completed

Conditions studied: Bradycardia

In brief

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.

Key facts

Study ID

NCT01299675

Run by

Medtronic

People needed

2483

Starts

2011-02-08

Expected to finish

2017-10-02

Last updated by the study team

2018-04-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — East Palo Alto, California, United States
• Study site — Fresno, California, United States
• Study site — Glendale, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Salinas, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Urbana, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Salisbury, Maryland, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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