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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT06150950
Eligibility Criteria:
Inclusion Criteria:
* Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \<50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 \< 50% predicted (by FRIEND equation)
* Age \>= 18 years old
Exclusion Criteria:
* Inotrope-dependence
* Symptomatic, uncontrolled arrhythmias
* Pregnancy
* Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
* Inability to comply with the protocol
* Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention
* Resting hypoxemia with baseline oxygen saturation \<80%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06150950
Study Brief:
Protocol Section:
NCT06150950