CryoValve® SG Aortic Human Heart Valve Combination Study

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Aortic Valve Stenosis, Aortic Valve Insufficiency

Intervention / Treatment
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* Procedure: Echocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients implanted with a CryoValve SGAV as an aortic valve replacement. Patients who were ≤ 21 years of age at the time of implant. Exclusion Criteria: Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit. Patients implanted with a CryoValve SGAV as a pulmonary valve replacement. Patients that were ≥ 22 years of age at the time of implant.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Patients<br>Pediatric (21 years of age or younger) patients who received a CryoValve SG Aortic Valve distributed during the 2000 to 2003 period as an aortic valve replacement. | Procedure: Echocardiogram<br>* A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve