Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Recruiting

• Conditions: Single-ventricle; Stenosis

• Registration Number: NCT07073612
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine change from baseline in exercise capacity after Fontan stenting.	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.	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.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States