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Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Recruitingn/aAges 12 Years - 21 YearsAllChildren's Hospital Los Angeles
NCT07073612 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Cardiopulmonary Exercise Testing (CPET)
  • Shear Wave Elastography Scan
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Where

1 site
Children's Hospital Los Angeles
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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