Actively Recruiting
Transcatheter Fontan Stenting Impact on Liver Stiffness and Exercise Capacity in Single-Ventricle Patients Aged 12 to 21
Led by Children's Hospital Los Angeles · Updated on 2025-07-18
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Fontan stent placement on exercise capacity and liver stiffness in patients aged 12 to 21 years who have single-ventricle heart conditions and have undergone Fontan palliation. The study aims to understand how this stenting procedure impacts these patients clinically, focusing on changes measured by exercise testing and liver scans. This observational study is sponsored by Children's Hospital Los Angeles and follows patients who require this procedure during their care. Participants will undergo Fontan stent placement for extracardiac Fontan conduit stenosis as determined by their primary heart specialist. The study does not involve assigning treatments but follows patients who receive this stent placement during their usual clinical care. Two main diagnostic tests are used: cardiopulmonary exercise testing on a cycle ergometer and shear wave elastography scans of the liver, performed before and after the stenting procedure at specific intervals. During the study, participants will complete two exercise tests and three liver stiffness scans over the course of about one year. These tests help researchers measure changes in exercise capacity and liver stiffness after stent placement. The study includes monitoring participants through standard clinical evaluations, and the main outcomes will be assessed one year after enrollment to understand the procedure's impact over time.
CONDITIONS
Brief 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 at the discretion of the primary operator
- Weight 250 kg or more
- Age between 12 and 21 years
You will not qualify if you...
- Interrupted inferior vena cava (IVC)
- Greater than mild atrioventricular valve regurgitation on recent echocardiogram or MRI (regurgitation fraction > 20%)
- Greater than mild systemic ventricular dysfunction on recent echo or MRI (ejection fraction < 40%)
- Non-sinus heart rhythm
- Presence of a pacemaker
- Unable to perform exercise test due to developmental or physical disability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months before cardiac catheterization
Participants undergo cardiopulmonary exercise testing and shear wave elastography scans before cardiac catheterization to assess baseline exercise capacity and liver stiffness.
1 to 2 visits
Duration - Up to 6 months following cardiac catheterization
Participants are monitored with repeated shear wave elastography scans and cardiopulmonary exercise testing after cardiac catheterization to assess changes in liver stiffness and exercise capacity.
2 to 3 visits
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
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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