Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636987
• Other study ID #: 0505
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Incompetence
• Aortic Valve Insufficiency
• Aortic Valve Regurgitation
• Aortic Valve Stenosis
• Constriction, Pathologic
• Mitral Valve Incompetence
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation
• Mitral Valve Stenosis

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