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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT02398604
Eligibility Criteria:
Inclusion Criteria:
* Subjects with hypoplastic left heart syndrome (all types) requiring BDCPA surgery.
Exclusion Criteria:
* Have HLHS and restrictive or intact atrial septum.
* Be undergoing the Norwood procedure that do not have HLHS.
* Have significant coronary artery sinusoids.
* Require mechanical circulatory support prior to surgery.
* Have an underlying evidence of arrhythmia requiring anti-arrhythmia therapy.
* Parent or guardian unwilling or unable to comply with necessary follow-up(s)
* Be serum positive for HIV, hepatitis BsAg (B Surface Antigen) or viremic hepatitis C.
* Be unsuitable for inclusion in the study, in the opinion of the investigator.
* Need for concomitant surgery for aortic coarctation or tricuspid valve repair.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT02398604
Study Brief:
Protocol Section:
NCT02398604