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COMPLETEDNANCT00636987

Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

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

Lead sponsor: Abbott Medical Devices•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Abbott Medical Devices

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 4, 2019Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment297

Start dateApr 2007

Last updatedFeb 4, 2019

Condition

Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence Mitral Valve Insufficiency+3 more

Locations shown

Scripps Green Hospital/Scripps Clinic

La Jolla, California

USC University Hospital, Department of Cardiothoracic Surgery

Los Angeles, California

The Heart Group, PC

Evansville, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2019Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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