Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Abbott Medical Devices297 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

297

Conditions

Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Stenosis Mitral Valve Incompetence

Interventions

Biocor and Biocor Supra valvesDEVICE

Replacement for a diseased, damaged, malformed aortic or mitral heart valve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Scripps Green Hospital/Scripps Clinic

La Jolla, California, United States

USC University Hospital, Department of Cardiothoracic Surgery

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Number of participants with Adverse Events

Time frame: 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.

Time frame: 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.

Time frame: 5 Year

Data from ClinicalTrials.gov

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