Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve
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 description
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.
Interventions
PROCEDUREEchocardiogram
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.
Sponsors
CryoLife, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 27 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Performance | 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 | 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 |
Countries
United States
Outcome results
None listed