Status:
COMPLETED
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
Lead Sponsor:
Medical University of South Carolina
Conditions:
Semilunar Heart Valve Replacement
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
The long-term goal of this research initiative is to develop a new valve replacement option for neonates, infants and young children. The central hypothesis is that transplantation of a freshly isolat...
Eligibility Criteria
Inclusion
- Children less than 2 years of age who are referred for a cardiac operation that involves a primary semilunar valve replacement or children less than 2 years of age who are referred for a cardiac operation involves an initial replacement of a previously placed prior homograft, bioprosthetic, or mechanical valve in the aortic or pulmonary position.
- Deemed acceptable for partial heart transplantation based on the standard evaluation process used for orthotopic heart transplantation (see Appendix 1) Insurance approval.
- Written informed consent of both parents/guardians; if there is only one parent/guardian, consent from that individual will be adequate.
Exclusion
- Absolute contraindications for orthotopic heart transplantation.
- Severe bilateral long segment pulmonary arterial hypoplasia
- Bilateral pulmonary vein stenosis
- \<34 weeks corrected gestational age
- Persistent acidosis with a pH \< 7.1
- Diagnosis of immune deficiency.
- Inability for the parent to understand English or Spanish.
- Failure to pass the following psychosocial evaluation:
- The candidate should reside within 4 hours traveling time from Medical University of South Carolina for a minimum of four to six months post-transplantation to assure careful follow-up
- The candidate's family should be capable of long-term supportive care of the child and be able to support the medical needs of the child in follow-up
- 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
- Infectious Disease Exclusion Criteria
- Evidence of sepsis
- Hepatitis B surface antigenemia
- HIV positivity
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05372757
Start Date
May 3 2023
End Date
November 30 2023
Last Update
September 19 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29401