Partial Heart Transplantation

Duke University

Status: Withdrawn

Conditions: Congenital Heart Disease

Treatments: Procedure: Partial Heart Transplantation; Other: Freshly procured valve

Study type: Interventional

Funder types: Other

Identifiers

NCT06055556

Pro00110600

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Partial Heart Transplantation

Experimental group

Description:

Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve.

Treatment:

Other: Freshly procured valve

Procedure: Partial Heart Transplantation