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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06055556
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Years
Study:
NCT06055556
Study Brief:
Protocol Section:
NCT06055556