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Trial record 1 of 2 for:    St. Jude BIOCOR
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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636987
First Posted: March 17, 2008
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

Condition Intervention
Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Stenosis Mitral Valve Incompetence Device: Biocor and Biocor Supra valves

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.


  • 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.



Enrollment: 297
Study Start Date: April 2007
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Heart Valve Replacement

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636987


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00636987     History of Changes
Other Study ID Numbers: 0505
First Submitted: March 10, 2008
First Posted: March 17, 2008
Results First Submitted: October 14, 2016
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: September 2015

Keywords provided by St. Jude Medical:
aortic valve
mitral valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve regurgitation
aortic valve stenosis
mitral valve regurgitation
mitral valve stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Mitral Valve Insufficiency
Aortic Valve Insufficiency
Mitral Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction