Partial Heart Transplantation

Not Applicable

Withdrawn

• Conditions: Congenital Heart Disease

• Registration Number: NCT06055556
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Potential participants are patients 12 and younger with congenital heart defects in need of pulmonary valve replacement.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 study procedure, tests, medications, and follow-up visits will all be done per standard of care for heart transplant patients. Data will be collected from chart review, before, during and after surgery and at standard of care follow-up visits. Study data will be compared to historical data of patients who have undergone other types of pulmonary valve replacement surgery.

Study Timeline

• Study Start: 2023-08-04
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of eligible patients who can be matched for transplant and the tissues needed procured	Day 1	A measure of feasibility.
To assess valve growth following partial heart transplantation.	Year 2	This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.

Secondary Outcome Measures

Name	Time	Method
To assess valve function following partial heart transplantation.	Year 2	This will be determined by looking for the development of valve stenosis over time based on post-operative imaging.
To determine whether valve replacement(s) using partial heart transplantation is safe.	Year 2	This will be determined by survival and major complication rates.

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States