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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00115934
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
* Planned Norwood procedure
* Informed consent of parent(s) or legal guardian
Exclusion Criteria:
* Single, morphologic left ventricle anomaly
* Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
* Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00115934
Study Brief:
Protocol Section:
NCT00115934