CryoValve® SG Aortic Human Heart Valve Combination Study

CryoLife, Inc.50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis Aortic Valve Insufficiency

Interventions

EchocardiogramPROCEDURE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 27 Years

Medical Language ↔ Plain English

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.

Locations (9)

Arizona Pediatric Cardiology Consultants

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Rady Children's Hospital

San Diego, California, United States

The Children's Hsopital

Outcomes

Primary Outcomes

Hemodynamic Performance

Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area

Time frame: 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

Time frame: From Implant until Study Enrollment (on average, 7 years)

Data from ClinicalTrials.gov

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