Clinical Trial: CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

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

Official Title: CryoValve SG Pulmonary Human Heart Valve Post Clearance Study

Brief Summary: The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

Detailed Summary: The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® 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: Most Recent follow-up (average of 3-6 years post implant) ]
    Peak Pulmonary Gradient Mean Pulmonary Gradient
  • Hemodynamic Performance [ Time Frame: Most Recent Follow-up (average of 4 to 6 years post implant) ]
    Pulmonary Insufficiency Grade
  • Safety Assessment [ Time Frame: Since Implant of the Valve to a Maximum of 13.0 years ]

    Evaluation of the following adverse events

    • Mortality (all cause and valve-related)
    • Reoperation/reintervention
    • Explant
    • Endocarditis
    • Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)
    • Thrombosis
    • Thromboembolism (pulmonary embolism)
    • Non-structural dysfunction
    • Perivalvular leak
    • Bleeding
    • Hemolysis
    • Calcification


Original Primary Outcome:

  • Hemodynamic Performance [ Time Frame: Yearly after Implant ]
    Peak Pulmonary Gradient Mean Pulmonary Gradient Pulmonary Insufficiency Grade
  • Safety Assessment [ Time Frame: Since Implant of the Valve ]

    Evaluation of the following adverse events

    • Mortality (all cause and valve-related)
    • Reoperation/reintervention
    • Explant
    • Endocarditis (all and valvular)
    • Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)
    • Thrombosis
    • Thromboembolism (pulmonary embolism)
    • Non-structural dysfunction
    • Perivalvular leak (all and major)
    • Bleeding (all and major)
    • Hemolysis
    • Calcification
    • Conduit failure


Current Secondary Outcome:

Original Secondary Outcome:

Information By: CryoLife, Inc.

Dates:
Date Received: March 23, 2010
Date Started: January 2010
Date Completion:
Last Updated: August 26, 2016
Last Verified: August 2016