Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Biocor and Biocor Supra valves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implanted with Biocor or Biocor Supra Valves<br> | Device: Biocor and Biocor Supra valves<br>* Replacement for a diseased, damaged, malformed aortic or mitral heart valve<br>* Other names: Heart Valve Replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Number of participants with Adverse Events | 5 Years | 
| Characterize Patient NYHA Functional Classification Status | 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. | 5 year | 
| Characterize the Hemodynamic Performance of the Valve | 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. | 5 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve, mitral valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve regurgitation, aortic valve stenosis, mitral valve regurgitation, mitral valve stenosis