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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03189134
Eligibility Criteria:
Inclusion Criteria:
* Males and females between 30 days and 21 years old
* Undergoing elective surgery for closure of atrial septal defect
* Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself
Exclusion Criteria:
* Prior history of adverse reaction to fluorescein sodium
* Prior history of renal failure or abnormal renal function
* Baseline PR interval \> 220 msec or 98% for age
* Baseline HR \> 87% for age
* Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Days
Maximum Age:
21 Years
Study:
NCT03189134
Study Brief:
Protocol Section:
NCT03189134