Status:
WITHDRAWN
Partial Heart Transplantation
Lead Sponsor:
Duke University
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 12 years
Phase:
NA
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...
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 con...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06055556
Start Date
August 4 2023
End Date
May 1 2025
Last Update
July 1 2025
Active Locations (1)
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1
Duke University Hospital
Durham, North Carolina, United States, 27710