Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00636987
First received: March 10, 2008
Last updated: August 8, 2014
Last verified: August 2014
  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: 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:
  • Establish adverse event rates [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Characterize patient NYHA functional classification status [ Time Frame: At required follow-up intervals ] [ Designated as safety issue: No ]
  • Characterize the hemodynamic performance of the valve [ Time Frame: At required follow-up visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636987

Locations
United States, California
Scripps Green Hospital/Scripps Clinic
LaJolla, 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
St. 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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00636987     History of Changes
Other Study ID Numbers: 0505
Study First Received: March 10, 2008
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014