Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 2007
End Date:March 2016

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Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

The purpose of this study is to further evaluate the long-term safety and effectiveness of
the Biocor and Biocor Supra Valves.

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.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
17
sites
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Norfolk, VA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Portland, ME
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Evansville, Indiana 47710
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Evansville, IN
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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Indianapolis, Indiana 46250
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Indianapolis, IN
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Kansas City, Missouri 64111
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Kansas City, MO
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Kingsport, Tennessee 37660
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Kingsport, TN
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La Jolla, California 92037
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La Jolla, CA
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Los Angeles, CA
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Manchester, New Hampshire 03102
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Manchester, NH
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Nashville, Tennessee 37205
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Nashville, TN
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Portland, OR
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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Ridgewood, NJ
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Saint Paul, Minnesota 55102
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Saint Paul, MN
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