Expired Study
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Bakersfield, California


Purpose:

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.


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


NCT ID:

NCT01299675


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bakersfield, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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