NCT07073612Recruiting
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Children's Hospital Los Angeles
Start Date
8/1/2025
Completion Date
12/1/2027
Summary
The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years old. The main question it aims to: -Assess changes in exercise capacity by cardiopulmonary exercise testing and liver stiffness assessed by shear wave elastography before and after EFC stenting. Participants will undergo two cardiopulmonary exercise tests and three shear wave elastography scans.
Eligibility Criteria
Age Range: 12 years to 21 years
Inclusion Criteria:
* Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization
* Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis at the discretion of the primary operator
* Weight ≥ 50 kg
* 12-21 years of age
Exclusion Criteria:
* Interrupted IVC
* Greater than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (RF \> 20%).
* Greater than mild systemic ventricular dysfunction on most recent echo or MRI (EF \< 40%).
* Non-sinus rhythm
* Pacemaker
* Inability to perform exercise test due to developmental or physical disability
Interventions
DIAGNOSTIC_TEST
Cardiopulmonary Exercise Testing (CPET)
DIAGNOSTIC_TEST
Shear Wave Elastography Scan
Conditions
Single-ventricleStenosis
Locations
Children's Hospital Los Angeles
Los Angeles, California 90027
United States