Fontan conduit stenting to lower liver stiffness and improve exercise capacity
Official title: Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Run by Children's Hospital Los Angeles · NCT07073612 · Data updated 2026-11-12
This project will see if placing a stent in an extracardiac Fontan conduit changes liver stiffness and exercise capacity in 12–21-year-olds with single-ventricle Fontan palliation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 21 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT07073612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are single-ventricle Fontan-palliated patients aged 12–21 years, weighing at least 50 kg, who are undergoing clinically indicated cardiac catheterization with anticipated EFC stent placement.
✕Probably not a fit
Patients with interrupted IVC, greater than mild AV valve regurgitation or ventricular dysfunction, non-sinus rhythm or a pacemaker, or those unable to perform exercise testing are unlikely to qualify or derive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adolescents and young adults (12–21 years, ≥50 kg) with single-ventricle Fontan palliation who undergo clinically indicated extracardiac Fontan conduit (EFC) stent placement. Participants will complete two cardiopulmonary exercise tests and three shear wave elastography scans performed before and after stent placement to measure changes in exercise capacity and liver stiffness. Stent placement is determined by the treating catheterization team and not assigned by the study. Researchers will compare pre- and post-stent measures within individuals to characterize physiologic changes after EFC stenting.
Why it matters
Potential benefit: If successful, the findings could show that EFC stenting improves liver stiffness and exercise capacity, helping clinicians decide when stenting may be beneficial for Fontan patients.
How similar studies have gone: Previous small case series and physiologic reports have shown stenting can relieve conduit obstruction and improve hemodynamics, but direct evidence linking EFC stenting to improved liver stiffness and exercise capacity is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Children's Hospital Los Angeles
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Neil Patel, MD — Children's Hospital Los Angeles
- Study coordinator: Molly Moxness
- Email: mmoxness@chla.usc.edu
- Phone: 3233619823
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.