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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:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00636987
First received: March 10, 2008
Last updated: April 26, 2017
Last verified: September 2015
March 10, 2008
April 26, 2017
April 2007
October 2015   (Final data collection date for primary outcome measure)
  • 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.

  • Establish adverse event rates [ Time Frame: Ongoing ]
  • Characterize Patient NYHA Functional Classification Status [ Time Frame: At required follow-up intervals ]
  • Characterize the Hemodynamic Performance of the Valve [ Time Frame: At required follow-up visits ]
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: No masking
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.
 
Completed
297
March 2016
October 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00636987
0505
No
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Urban Lonn, MD, PhD St. Jude Medical
St. Jude Medical
September 2015

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