Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Completed · Not applicable

Conditions studied: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Stenosis, Mitral Valve Incompetence

In brief

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

Key facts

Study ID

NCT00636987

Run by

Abbott Medical Devices

People needed

297

Starts

2007-04-01

Expected to finish

2016-03-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Green Hospital/Scripps Clinic — La Jolla, California, United States
• USC University Hospital, Department of Cardiothoracic Surgery — Los Angeles, California, United States
• The Heart Group, PC — Evansville, Indiana, United States
• Indiana Heart Hospital — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• HealthEast St. Joseph Hospital — Saint Paul, Minnesota, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States
• Saint Thomas Hospital — Nashville, Tennessee, United States
• Sentara Norfolk General Hospital/Sentara Heart Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.