NCT07073612

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: —

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.

Conditions

• Single-ventricle
• Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States