Home › Univentricular Heart › NCT07073612
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Who can join
Ages 12 to 21 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Cardiopulmonary Exercise Testing (CPET) (diagnostic test)
- Shear Wave Elastography Scan (diagnostic test)
Sponsor: Children's Hospital Los Angeles · Participants: 20 · Started: Aug 1, 2025
Contact the study team
- Molly Moxness · Phone: 3233619823
Official record on ClinicalTrials.gov — NCT07073612
Locations in the U.S.
| California | Children's Hospital Los Angeles, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.