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RECRUITING
NCT07073612

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Sponsor: Children's Hospital Los Angeles

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Years - 21 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-08-01

Completion Date

2027-12-01

Last Updated

2025-07-18

Healthy Volunteers

Not specified

Interventions

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.

Locations (1)

Children's Hospital Los Angeles

Los Angeles, California, United States