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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT05199857
Eligibility Criteria:
Inclusion Criteria:
* Males and females with Fontan physiology who are 13 to \<19 years of age at enrollment
* Own a mobile device capable of installing the University of Michigan Patient Portal application
* Fluent in English
* Participant consent or parental/guardian consent and participant assent
Exclusion Criteria:
* Height \< 130 centimeters
* Current intravenous inotropic drugs
* Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
* Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
* History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms).
* Inability to complete exercise testing at baseline screening.
* Noncardiac medical, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
* Suicidality or homicidality in the past 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT05199857
Study Brief:
Protocol Section:
NCT05199857