Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Launched by CHILDREN'S HOSPITAL LOS ANGELES · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a procedure called Fontan stenting affects heart function and liver health in young patients who have a single-ventricle heart condition. Specifically, the study looks at children and young adults aged 12 to 21 who have a narrowed part in their heart’s extracardiac Fontan conduit—a tube used to help blood flow in these patients. Researchers want to see if placing a stent (a small mesh tube) to open up this narrowed area improves how well participants can exercise and whether it reduces liver stiffness, which can be a sign of liver problems.

To take part, patients need to have this single-ventricle heart condition and be already scheduled for a heart catheterization procedure, during which the stent may be placed. Participants must weigh at least 50 kg (about 110 pounds) and be able to perform exercise tests. During the study, they will have two exercise tests to measure their heart and lung function and three liver scans to check liver stiffness—both before and after the stent placement. The trial is currently recruiting and welcomes all genders. It’s important to note that some patients won’t be eligible, such as those with certain heart rhythm problems, pacemakers, or who can’t safely perform exercise tests. This study aims to help doctors better understand the benefits of Fontan stenting on overall health and quality of life for patients with this complex heart condition.

Gender

ALL

Eligibility criteria

• 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