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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT05617534
Eligibility Criteria:
Inclusion Criteria:
* Patients with Fontan circulation, age range 8 to 18 years
* Ability to perform a cardiopulmonary exercise stress test (CPET)
* Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance
* Who have had a Fontan operation at least six months prior.
Exclusion Criteria:
* Existing neuro-disability i.e. with paresis post cerebrovascular accident
* Neurodevelopmental issue with inability to comply with commands.
* Documented life-threatening arrhythmia without implantable cardioverter defibrillator
* Moderate or severe atrio-ventricular valve regurgitation
* Moderate or severe ventricular dysfunction by echocardiography exams
* Acute inflammatory cardiac disease
* documented coronary artery stenosis and/or myocardial ischaemia
* Heart failure requiring hospitalisation in the past year
* Evidence of systemic venous pathway obstruction by echocardiography or catheterisation
* Resting oxygen saturation \< 90%
* Systemic ventricular outflow tract stenosis with peak resting systolic gradient \> 50mmHg
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT05617534
Study Brief:
Protocol Section:
NCT05617534