Trials / Completed
CompletedNCT01299675
SureScan Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,483 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2011-02-08
- Primary completion
- 2017-10-02
- Completion
- 2017-10-02
- First posted
- 2011-02-18
- Last updated
- 2018-04-27
Locations
61 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01299675. Inclusion in this directory is not an endorsement.