Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT05372757
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
2 Years
Study:
NCT05372757
Study Brief:
Protocol Section:
NCT05372757