WithdrawnNot Applicable

Partial Heart Transplantation

Stopped: Study no longer needed.

United States0Started 2023-08-04

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Contraindication for heart transplantation * Severe bliateral long segment pulmonary arterial hypoplasia * Bilateral pulmonary vein stenosis * Persistent acidosis with a pH \< 7.1 * Failure to pass psychosocial evaluation * Parental (custodial) alcohol and/or substance abuse * Documented parental (custodial) child abuse or neglect * Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen * Infection disease exclusion criteria * Evidence of active sepsis * Hepatitis B surface antigenemia * HIV positivity * Pregnancy * Financial hardship or insurance non-approval

What they're measuring

Number of eligible patients who can be matched for transplant and the tissues needed procured

Timeframe: Day 1

To assess valve growth following partial heart transplantation.

Timeframe: Year 2

Trial details

NCT IDNCT06055556

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01