Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 297
- Locations
- 34
- Primary Endpoint
- Characterize the Hemodynamic Performance of the Valve
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Characterize the Hemodynamic Performance of the Valve
Time Frame: 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
Time Frame: 5 Years
Number of participants with Adverse Events
Characterize Patient NYHA Functional Classification Status
Time Frame: 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 Outcomes
No secondary outcomes reported