Clinical Trial: CryoValve® SG Aortic Human Heart Valve Combination Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

Brief Summary: The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.

Detailed Summary: The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.
Sponsor: CryoLife, Inc.

Current Primary Outcome:

  • Hemodynamic Performance [ Time Frame: From Implant until Study Enrollment (on average, 7 years) ]
    Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area
  • Number of Adverse Events as a Measure of Safety [ Time Frame: From Implant until Study Enrollment (on average, 7 years) ]

    Safety parameters will follow the guidelines for reporting morbidity and mortality after cardiac valvular operations as established by The American Association for Thoracic Surgery and The Society of Thoracic Surgeons.

    Evaluation of the following adverse events:

    • Mortality (all cause and valve-related)
    • Reoperation/reintervention
    • Explant
    • Endocarditis (all and valvular)
    • Thrombosis
    • Thromboembolism
    • Non-structural dysfunction
    • Perivalvular leak (all and major)
    • Bleeding (all and major)
    • Hemolysis
    • Calcification
    • Conduit failure


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: CryoLife, Inc.

Dates:
Date Received: October 1, 2010
Date Started: June 2010
Date Completion:
Last Updated: August 17, 2015
Last Verified: August 2015