RecruitingNCT07073612

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Sponsor

Children's Hospital Los Angeles

Enrollment

20 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

Stenosis Single Ventricle

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.

Eligibility

Min Age: 12 YearsMax Age: 21 Years

Inclusion Criteria4

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
-21 years of age

Exclusion Criteria6

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

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Interventions

DIAGNOSTIC_TESTCardiopulmonary 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_TESTShear 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.