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Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Sponsor: Children's Hospital Los Angeles
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.
Key Details
Gender
All
Age Range
12 Years - 21 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2025-08-01
Completion Date
2027-12-01
Last Updated
2025-07-18
Healthy Volunteers
Not specified
Conditions
Interventions
Cardiopulmonary Exercise Testing (CPET)
CPET will be performed on a cycle ergometer using a ramp protocol designed to achieve an exercise time of 8-12 min. The entire procedure duration is approximately 60 min. CPET will be completed 6 months to 1 day before the cardiac catheterization and will be repeated 3-6 months following cardiac catheterization.
Shear Wave Elastography Scan
The study lasts approximately 20 minutes. Shear Wave Elastography will be completed 6 months to 1 day before the cardiac catheterization. The Scan will be repeated 2-4 weeks following cardiac catheterization, and 3-6 months following cardiac catheterization.
Locations (1)
Children's Hospital Los Angeles
Los Angeles, California, United States