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Completed

NCT Number: NCT00636987

Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

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Key information

Conditions

Aortic Valve Insufficiency Aortic Valve Disease Aortic Valve Incompetence Aortic Valve Regurgitation Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Incompetence Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Stenosis Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Green Hospital/Scripps Clinic, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biocor and Biocor Supra valves

Device

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

Other names: Heart Valve Replacement

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 5 Years

    Number of participants with Adverse Events

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

Important dates

Study start
2007
Primary completion
2015
Study completion
2016
First posted
Mar 17, 2008
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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