Heart Valve Transplantation Using Donor Valves for Patients Aged 30 Days to 50 Years to Improve Valve Function and Growth

What this Trial Is About

Heart valves in children and young adults may need replacement or repair, but many current options do not grow as the patient grows. This research aims to study the outcomes of allogeneic heart valve transplantation, where valves from organ donors are implanted into patients needing new heart valves. The trial focuses on children and adults who require valve replacement and may have limited options due to growth potential or risk of prosthetic valve failure. Participants will receive a transplanted heart valve from an organ donor, specifically for aortic, pulmonary, mitral, or tricuspid valve replacement. The procedure involves implanting a valve that may grow with the patient over time, potentially reducing the need for multiple surgeries. This is a single-arm interventional trial without masking or blinding, and it includes follow-up of valve function and growth over one year and survival over five years. During the study, participants will be monitored at Boston Childrens Hospital for valve regurgitation, valve annulus growth, and leaflet growth at one year. Additional assessments will include ventricular function and survival up to five years. Patients and their families must be able to travel quickly for the transplant and maintain follow-up care, including medical record authorization for five years. The total commitment involves ongoing monitoring to evaluate the transplanted valves performance and any potential side effects.

Allogeneic Valve Transplantation