Fontan conduit stenting to lower liver stiffness and improve exercise capacity
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07073612 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.