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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

March 10, 2008
February 15, 2013
April 2007
April 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00636987 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Other Name: Heart Valve Replacement
Implanted with Biocor or Biocor Supra Valves
Intervention: Device: Biocor and Biocor Supra valves
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2016
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kelly Erickson 651-756-6580 kaerickson@sjm.com
United States
 
NCT00636987
0505
No
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Urban Lonn, MD, PhD St. Jude Medical
St. Jude Medical
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP