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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT03897335
Eligibility Criteria:
Inclusion Criteria:
Cohort 1
* All children undergoing open heart surgery for congenital heart defects with or without circulatory arrest
* Neonates (\<28 days old) and infants (\<1 years of age)
* Hypoplastic L heart syndrome or its variants.
* Coarctation with aortic arch hypoplasia.
* Interrupted aortic arch.
* TAPVR (Total anomalous pulmonary venous return)
* Patients with complex congenital heart defects
Cohort 2:
* Orthotopic heart transplantation patients.
* Patients ≤ 18 years of age
* Congenital heart defects
* Cardiomyopathy (Dilated/Hypertrophic/Restrictive/Left Ventricular Non-compaction)
Exclusion Criteria:
* Children under the age of 12 months undergoing bypass for any condition that is not categorized as congenital heart defect
* History of seizures
* History of significant tachyarrhythmia.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03897335
Study Brief:
Protocol Section:
NCT03897335