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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00636987
Other study ID # 0505
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2007
Est. completion date March 2016

Study information

Verified date January 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 297
Est. completion date March 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Intervention

Device:
Biocor and Biocor Supra valves
Replacement for a diseased, damaged, malformed aortic or mitral heart valve

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events Number of participants with Adverse Events 5 Years
Primary 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
Primary 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
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