Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Mitral Valve Stenosis; Mitral Valve Regurgitation; Aortic Valve Incompetence; Mitral Valve Incompetence; Aortic Valve Regurgitation
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92103
      • Scripps Green Hospital/Scripps Clinic
    • Los Angeles, California, United States, 90033
      • USC University Hospital, Department of Cardiothoracic Surgery
  • Indiana
    • Evansville, Indiana, United States, 47710
      • The Heart Group, PC
    • Indianapolis, Indiana, United States, 46240
      • Indiana Heart Hospital
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson Medical School
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital/Sentara Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implanted with Biocor or Biocor Supra Valves	Device: Biocor and Biocor Supra valves; Replacement for a diseased, damaged, malformed aortic or mitral heart valve; Other Names: Heart Valve Replacement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Urban Lonn, MD, PhD, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 10, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 17, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: cardiac surgery; bioprosthesis; aortic valve stenosis; mitral valve; aortic valve; heart valve; tissue valve; valve disorder; valve disease; aortic valve regurgitation; mitral valve regurgitation; mitral valve stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Constriction, Pathologic; Mitral Valve Stenosis
• Other Study ID Numbers: 0505