NCT07073612 · Children's Hospital Los Angeles
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
What this study 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
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.
DIAGNOSTIC_TEST
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.
Primary outcome measures
Determine change from baseline in exercise capacity after Fontan stenting.
Time frame: 1 year post enrollment
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting.
Time frame: 1 year post enrollment
FibroScan will be used to assess liver stiffness before catheterization, at 2-4 weeks following stent placement, and 3-6 months following stent placement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Inability to perform exercise test due to developmental or physical disability
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations