Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00636987

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

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

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:	360
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Replacement for a diseased, damaged, malformed aortic or mitral heart valve

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

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

Locations

United States, California
USC University Hospital, Department of Cardiothoracic Surgery	Recruiting
Los Angeles, California, United States, 1520 San Pablo St., Suite 4300
Contact: Becky M. Lopez, RN 323-442-6226 bmlopez@surgery.usc.edu
Contact: Candace W. Bart, RN 323-442-5849
Principal Investigator: Vaughn A. Starnes, MD
Sub-Investigator: Mark J. Cunningham, MD
Sub-Investigator: Craig Baker, MD
Scripps Green Hospital/Scripps Clinic	Recruiting
LaJolla, California, United States, 92103
Contact: Eileen Anderson, Clinical Trial Coordinator 858-554-5046 anderson.eileen@scrippshealth.org
Contact: Marybeth Gutierrez, MA, Research Assistant 858-554-5341 gutierrez.marybeth@scrippshealth.org
Principal Investigator: Jeffery J. Tyner, M.D.
Sub-Investigator: James R. Hemp, MD
Sub-Investigator: Joelle M. Coletta, MD
United States, Maine
Maine Medical Center	Recruiting
Portland, Maine, United States, 04102
Contact: Jane C. Kane, BSN 207-662-6991 kanejan@mmc.org
Principal Investigator: Paul William Weldner, MD
Sub-Investigator: Louis Russo, MD
Sub-Investigator: Scott A. Buchanan, MD
United States, Oregon
Providence St. Vincent Medical Center	Recruiting
Portland, Oregon, United States, 97225
Contact: Eric M Johnson, BA 503-216-2075 eric.johnson@providence.org
Principal Investigator: Jeffrey S. Swanson, MD
Sub-Investigator: Hugh Gately, MD
Sub-Investigator: Anthony P. Furnary, MD
United States, Tennessee
Saint Thomas Hospital	Recruiting
Nashville, Tennessee, United States, 37205
Contact: Janet G. Dunn, RN, MSN 615-222-4356 JDunn@STThomas.org
Contact: Cindy Beesley, BS 615-222-3365 CBeesley@STThomas.org
Principal Investigator: Todd Shuman, MD
Sub-Investigator: David Glassford, MD
Sub-Investigator: William Coltharp, MD
Sub-Investigator: Mark Tedder, MD
Sub-Investigator: John W. Lea, MD
United States, Texas
Cardiothoracic & Vascular Surgeons	Recruiting
Austin, Texas, United States, 78703
Contact: Donna Johnson, BSMT 512-459-8753 donna@ctvstexas.com
Principal Investigator: Mark C. Felger, MD
Sub-Investigator: John D. Oswalt, MD
Sub-Investigator: Stephen J. Dewan, MD
Sub-Investigator: Michael C. Mueller, MD
Sub-Investigator: Andrew T. Hume, MD
Sub-Investigator: Staton L. Awtrey, MD
Sub-Investigator: William F. Kessler, MD
United States, Virginia
Sentara Norfolk General Hospital/Sentara Heart Hospital	Recruiting
Norfolk, Virginia, United States, 23507
Contact: Laura Pine, RN, BSN 757-388-2732 ljpine@sentara.com
Contact: Michelle Collier, RN, BSN 757-388-7511 mlcollie@sentara.com
Principal Investigator: Joseph Newton, MD
Sub-Investigator: Michael McGrath, MD
Sub-Investigator: Kirk Fleischer, MD

Sponsors and Collaborators

St. Jude Medical

More Information

No publications provided

Responsible Party:	St. Jude Medical, Inc., Cardiovascular Division ( Senior Director, Clinical Affairs )
Study ID Numbers:	0505
Study First Received:	March 10, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00636987 History of Changes
Health Authority:	United States: Institutional Review Board

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Heart Diseases
Aortic Valve Insufficiency
Mitral Valve Stenosis

Constriction, Pathologic
Aortic Valve Stenosis
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Heart Diseases
Aortic Valve Insufficiency
Mitral Valve Stenosis
Cardiovascular Diseases

Constriction, Pathologic
Aortic Valve Stenosis
Ventricular Outflow Obstruction
Heart Valve Diseases
Mitral Valve Insufficiency

ClinicalTrials.gov processed this record on May 07, 2009