NCT06055556

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

August 23, 2023

Last Update Submit

June 26, 2025

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Number of eligible patients who can be matched for transplant and the tissues needed procured

    A measure of feasibility.

    Day 1

  • 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 Outcomes (2)

  • To determine whether valve replacement(s) using partial heart transplantation is safe.

    Year 2

  • To assess valve function following partial heart transplantation.

    Year 2

Study Arms (1)

Partial Heart Transplantation

EXPERIMENTAL

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.

Procedure: Partial Heart TransplantationOther: Freshly procured valve

Interventions

Partial Heart TransplantationPROCEDURE

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".

Partial Heart Transplantation
Freshly procured valveOTHER

Fresh donor graft semilunar heart valve.

Partial Heart Transplantation

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Evidence of active sepsis
  • Hepatitis B surface antigenemia
  • HIV positivity
  • Pregnancy
  • Financial hardship or insurance non-approval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Joseph Turek, MD, PhD, MBA

    Duke Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 26, 2023

Study Start

August 4, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)