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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

This study is currently recruiting participants.
Verified February 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00636987
First received: March 10, 2008
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636987

Contacts
Contact: Kelly Erickson 651-756-6580 kaerickson@sjm.com

Locations
United States, Arizona
University of Arizona Dept. of Cardiothoracic Surgery, University Medical Center Withdrawn
Tucson, Arizona, United States, 85724
United States, California
Scripps Green Hospital/Scripps Clinic Active, not recruiting
LaJolla, California, United States, 92103
USC University Hospital, Department of Cardiothoracic Surgery Recruiting
Los Angeles, California, United States, 90033
Contact: Becky M. Lopez, RN     323-442-6226     bmlopez@surgery.usc.edu    
Contact: Shadi Van Trease, BA, CCRC     323-442-6252     shadi.vantrease@med.use.edu    
Principal Investigator: Vaughn A. Starnes, MD            
Sub-Investigator: Mark J. Cunningham, MD            
Sub-Investigator: Craig Baker, MD            
Sub-Investigator: Michael Bowdish, MD            
United States, Indiana
The Heart Group, PC Recruiting
Evansville, Indiana, United States, 47710
Contact: Amanda Johnson, CNA     812-490-4505     amanda.johnson@deaconess.com    
Contact: Michelle C Goebel     812-858-5796        
Principal Investigator: Lee A. Wagmeister, MD            
Sub-Investigator: Dominic C. Cefali, MD            
Indiana Heart Hospital Recruiting
Indianapolis, Indiana, United States, 46240
Contact: Joanna Greene-Nashold, RN, BSN     317-621-8629     jgreenenashold@ecommunity.com    
Contact: Tonika Peterson     317-621-8630     tpeterson@ecommunity.com    
Principal Investigator: Gregory K Dedinsky, M.D., FACS            
United States, Maine
Maine Medical Center Active, not recruiting
Portland, Maine, United States, 04102
United States, Minnesota
HealthEast St. Joseph Hospital Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Joy Gilliam, LPN, CCRC     651-471-2653     jegilliam@healtheast.org    
Contact: Beth Jorgenson, RN, BSN     651-232-3274     bjorgenson@healtheast.org    
Principal Investigator: David Joyce, MD            
Sub-Investigator: Jan Hommerding, PA            
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Brent A. Buckman, BSN     816-932-4828     bbuckman@saint-lukes.org    
Contact: Paul Kennedy, RN     816-932-8667     pkennedy@saint-lukes.org    
Sub-Investigator: Keith B. Allen, MD            
Principal Investigator: A. Michael Borkon, MD            
Sub-Investigator: Alex Pak, MD            
Sub-Investigator: R. Scott Stuart, MD            
Sub-Investigator: James R. Stewart, MD            
United States, New Hampshire
Catholic Medical Center Recruiting
Manchester, New Hampshire, United States, 03102
Contact: Allison Salinder, RN, CCRN     603-897-5228     allisonsalinder@gmail.com    
Contact: Lynn Monroe     603-897-5228        
Principal Investigator: Yvon Baribeau, MD            
Sub-Investigator: Benjamin Westbrook, MD            
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Ann Marie Lozano, RN MSN CCRC     732-235-3526     lozanoan@umdnj.edu    
Principal Investigator: Anthony Lemaire, M.D.            
Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Michelle Singer, RN         msinger@valleyhealth.com    
Contact: Kathleen B. Sayles, RN, BSN     201-447-8453     ksayles@valleyhealth.com    
Principal Investigator: Alex Zapolanski, MD            
Sub-Investigator: Jason Sperling, MD            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joseph F. Sabik, M.D.     216-444-6788     sabikj@ccf.org    
Contact: Roberta Palumbo     216-444-8774     Palumbr@ccf.org    
Principal Investigator: Joseph F. Sabik, M.D.            
United States, Oregon
Providence St. Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Andrea N Myers, RN     717-531-1452     anmyers@psu.edu    
Contact: Dena Jefferson, RN     717-531-5967     djefferson1@hmc.psu.edu    
Principal Investigator: Walter E. Pae, MD            
Sub-Investigator: Michael J. Lazar, MD            
Sub-Investigator: Edward R. Stephenson, MD            
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica L Howard, BS     215-410-6987     Jessica.Howard@uphs.upenn.edu    
Principal Investigator: Y. Joseph Woo, MD            
Sub-Investigator: Joseph E Bavaria, MD            
Sub-Investigator: Nimesh Desai, MD            
United States, South Carolina
RSFH: Roper Hospital, Heart & Vascular Center Withdrawn
Charleston, South Carolina, United States, 29401
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Jan P Cross, RN     423-230-5000     jcross@mycva.com    
Contact: Terrie W Walker, RN, BSN     423-230-5643     twalker@mycva.com    
Principal Investigator: D. Tyler Greenfield, MD            
Sub-Investigator: Stanley A Gall, MD            
Saint Thomas Hospital Active, not recruiting
Nashville, Tennessee, United States, 37205
United States, Virginia
Sentara Norfolk General Hospital/Sentara Heart Hospital Active, not recruiting
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: February 15, 2013
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:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Mitral Valve Insufficiency
Mitral Valve Stenosis
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013