Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-08-04
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Partial Heart Transplantation
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.
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".
Freshly procured valve
Fresh donor graft semilunar heart valve.
Interventions
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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".
Freshly procured valve
Fresh donor graft semilunar heart valve.
Eligibility Criteria
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Inclusion Criteria
* Deemed acceptable for partial heart transplantation based on the standard evaluation process
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Joseph Turek, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Hospital
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00110600
Identifier Type: -
Identifier Source: org_study_id
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