Congenital Heart Disease
Conditions
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.
Interventions
PROCEDUREPartial Heart Transplantation
Partial heart transplantation involves surgical replacement of the semilunar heart valve with a fresh donor graft. The surgical procedure (homograft valve replacement) is common and standard of care. The investigational aspect of this is using a freshly procured valve rather than a cryopreserved, cadaveric one and also the use of limited immunosuppression to help maintain the freshly procured valve as living tissue.
OTHERFreshly procured valve
Fresh donor graft semilunar heart valve.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To determine whether valve replacement(s) using partial heart transplantation is safe. | Year 2 | This will be determined by survival and major complication rates. |
| 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. |
Countries
United States
Outcome results
None listed