Allogeneic Valve Transplantation

Launched by BOSTON CHILDREN'S HOSPITAL · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to replace heart valves for patients who have serious valve heart disease. In this trial, heart valves from organ donors will be used to replace damaged valves in patients who need them. This approach aims to provide a more durable solution compared to traditional artificial valves. The study is currently recruiting participants, and anyone aged 30 days to 50 years who needs a valve replacement may be eligible, especially if they have limited options for replacement and can travel to the study site for treatment.

Participants in the trial can expect to receive a donated heart valve and will need to attend follow-up appointments at the hospital for five years after the procedure. It's important that participants and their families understand the requirements, such as being able to travel quickly to the hospital and maintaining regular check-ups during the study. This trial could offer a new hope for those who are struggling with valve diseases and have not found effective solutions through conventional treatments.

Gender

ALL

Eligibility criteria

• • 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