Actively Recruiting
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Led by Children's Hospital Los Angeles · Updated on 2025-07-18
20
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization
- Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis as determined by the primary operator
- Weight at least 50 kg
- Age between 12 and 21 years
You will not qualify if you...
- Interrupted inferior vena cava (IVC)
- More than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (regurgitant fraction greater than 20%)
- More than mild systemic ventricular dysfunction on most recent echocardiogram or MRI (ejection fraction less than 40%)
- Non-sinus heart rhythm
- Presence of pacemaker
- Inability to perform exercise test due to developmental or physical disability
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
M
Molly Moxness
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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