Clinical Research Directory

Inclusion Criteria * Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement. * Pediatric patients 30 days or older and \< 18 years, and adult patients 18-50 yrs. o Particularly patients with significant growth potential * Insufficient options are available for valve replacement o Patients at risk of immunogenic bio-prosthetic valve failure * Discussion with patient /family - option for durable valve rather than traditional prosthesis * ABO compatible * Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization * Patients that are able to maintain follow-up at BCH during the duration of the study * Patients that are able to provide medical record authorization for 5 year follow-up Exclusion Criteria * Age \< 30 days * Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely * Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic) * Morbid obesity (BMI\>35) * Diabetes mellitus with evidence of end-organ damage * Severe chromosomal, neurologic or syndromic abnormalities * Immunocompromised condition (DiGeorge, SCID etc.) * Active infection * History of endocarditis * HIV or chronic hepatitis B or C infection * Malignancy within 5 years prior to transplant * Severe renal or liver failure * Inadequate social support for post-transplant management * Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior * Evidence of large stroke with high risk for hemorrhagic conversion * Heart transplant recipient * Patients that are unable to follow-up during the initial 6 month window * Patients that are unable to provide medical record authorization for 5 years