SureScan Post-Approval Study
NCT01299675 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2483
Last updated 2018-04-27
Summary
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.
Conditions
- Bradycardia
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-08
- Primary Completion
- 2017-10-02
- Completion
- 2017-10-02
Countries
- United States
- Canada
Study Locations
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