Partial Heart Transplantation
Reason given: Study no longer needed.
Key facts
- Where
- Durham, United StatesSee the site
Where in United States
- Duke University HospitalDurham, United StatesNo longer taking part
Trial details
- Who runs it
- Duke University
- Trial code
- NCT06055556
- Record updated
- 1 July 2025
- Original description
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.Read full original descriptionShow less
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.
Inclusion: Congenital heart patient referred for a cardiac operation that involves valve replacement in pulmonary position; Deemed acceptable for partial heart transplantation based on the standard evaluation process.
Exclusion: Contraindication for heart transplantation; Failure to pass psychosocial evaluation; Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen; Infection disease exclusion criteria; Hepatitis B surface antigenemia; HIV positivity; Severe bliateral long segment pulmonary arterial hypoplasia; Bilateral pulmonary vein stenosis; Persistent acidosis with a pH < 7.1; Parental (custodial) alcohol and/or substance abuse; Documented parental (custodial) child abuse or neglect; Evidence of active sepsis; Pregnancy; Financial hardship or insurance non-approval.