Status:
COMPLETED
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Insufficiency
Aortic Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 B...
Eligibility Criteria
Inclusion
- Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time)
- Legal age
- Signed informed consent prior to surgery
- Willing to complete all follow-up requirements
Exclusion
- Pregnant or nursing women
- Already have had a valve replaced other than that for the scheduled replacement
- Needs another valve replaced
- Cannot return for required follow-up visits
- Have active endocarditis
- Acute preoperative neurological event (such as a stroke)
- Renal dialysis
- History of substance abuse within one year or is a prison inmate
- Participating in another study
- Had the Biocor or Biocor Supra valve implanted but then the device was explanted
- Life expectancy less than five years
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00636987
Start Date
April 1 2007
End Date
March 1 2016
Last Update
February 4 2019
Active Locations (17)
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1
Scripps Green Hospital/Scripps Clinic
La Jolla, California, United States, 92103
2
USC University Hospital, Department of Cardiothoracic Surgery
Los Angeles, California, United States, 90033
3
The Heart Group, PC
Evansville, Indiana, United States, 47710
4
Indiana Heart Hospital
Indianapolis, Indiana, United States, 46240