Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Not Applicable

Completed

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

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 Biocor Supra Valves.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Implanted with Biocor or Biocor Supra Valves	Biocor and Biocor Supra valves	-

Primary Outcome Measures

Name	Time	Method
Characterize the Hemodynamic Performance of the Valve	5 Year	Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.
Number of Participants With Adverse Events	5 Years	Number of participants with Adverse Events
Characterize Patient NYHA Functional Classification Status	5 year	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.

Secondary Outcome Measures

Name	Time	Method

Locations (17): 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
HealthEast St. Joseph Hospital
🇺🇸
Saint Paul, Minnesota, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Sentara Norfolk General Hospital/Sentara Heart Hospital
🇺🇸
Norfolk, Virginia, United States
Indiana Heart Hospital
🇺🇸
Indianapolis, Indiana, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Saint Thomas Hospital
🇺🇸
Nashville, Tennessee, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Catholic Medical Center
🇺🇸
Manchester, New Hampshire, United States
Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Robert Wood Johnson Medical School
🇺🇸
New Brunswick, New Jersey, United States
Wellmont Holston Valley Medical Center
🇺🇸
Kingsport, Tennessee, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States