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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01815502
Eligibility Criteria:
Inclusion Criteria:
* Presence of a congenital heart defect that leads to single ventricle physiology
* Previously performed Fontan surgery
Exclusion Criteria:
* The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization of within 1 month of catheterization
* Unstable arrhythmia at the time of catheterization
* History of unstable arrhythmia within 2 months of catheterization
* Venous, arterial or cardiac malformation that precludes the proper placement of a microconductance catheter
* Allergy to sildenafil or previous significant adverse reaction to sildenafil (e.g. hypotension)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
40 Years
Study:
NCT01815502
Study Brief:
Protocol Section:
NCT01815502