The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
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.
Study Type
OBSERVATIONAL
Enrollment
140
Patients will have a yearly echocardiogram after enrollment in the study.
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, United States
Indiana University
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Hemodynamic Performance
Peak Pulmonary Gradient Mean Pulmonary Gradient
Time frame: Most Recent follow-up (average of 3-6 years post implant)
Hemodynamic Performance
Pulmonary Insufficiency Grade
Time frame: Most Recent Follow-up (average of 4 to 6 years post implant)
Safety Assessment
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
Time frame: Since Implant of the Valve to a Maximum of 13.0 years
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Oklahoma University Health and Sciences Center
Oklahoma City, Oklahoma, United States
Cardiothoracic and Vascular Surgeons and Austin Heart
Austin, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States