SureScan Post-Approval Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 4/29/2018 |
Start Date: | February 8, 2011 |
End Date: | October 2, 2017 |
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.
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.
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
We found this trial at
60
sites
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