Clinical trial NCT06055556: Partial Heart Transplantation
Official title: Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 15
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of eligible patients who can be matched for transplant and the tissues needed procured
timeFrame: Day 1
measure: To assess valve growth following partial heart transplantation.
timeFrame: Year 2
Secondary outcomes:
measure: To determine whether valve replacement(s) using partial heart transplantation is safe.
timeFrame: Year 2
measure: To assess valve function following partial heart transplantation.
timeFrame: Year 2
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke Health
name: Joseph Turek, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: