Trials / Completed
CompletedNCT00636987
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 297 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Detailed description
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
Conditions
- Aortic Valve Insufficiency
- Aortic Valve Regurgitation
- Aortic Valve Stenosis
- Aortic Valve Incompetence
- Mitral Valve Insufficiency
- Mitral Valve Regurgitation
- Mitral Valve Stenosis
- Mitral Valve Incompetence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biocor and Biocor Supra valves | Replacement for a diseased, damaged, malformed aortic or mitral heart valve |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2015-10-01
- Completion
- 2016-03-01
- First posted
- 2008-03-17
- Last updated
- 2019-02-04
- Results posted
- 2017-06-02
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00636987. Inclusion in this directory is not an endorsement.