Partial Heart Transplantation

Congenital Heart Disease Clinical Trial

Official title:

Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06055556
• Other study ID #: Pro00110600
• Status: Suspended
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: December 30, 2030

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Partial 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".

Other:
• Freshly procured valve
Fresh donor graft semilunar heart valve.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eligible patients who can be matched for transplant and the tissues needed procured	A measure of feasibility.	Day 1
Primary	To assess valve growth following partial heart transplantation.	This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.	Year 2
Secondary	To determine whether valve replacement(s) using partial heart transplantation is safe.	This will be determined by survival and major complication rates.	Year 2
Secondary	To assess valve function following partial heart transplantation.	This will be determined by looking for the development of valve stenosis over time based on post-operative imaging.	Year 2