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NCT Number: NCT07073612

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

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.

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Key information

Conditions

Single-ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Heart Defects, Congenital Heart Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stenosis Univentricular Heart

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Molly Moxness

CONTACT

[email protected]

3233619823

Neil Patel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary exercise testing (CPET)

Diagnostic Test

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.

Shear Wave Elastography Scan

Diagnostic Test

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.

Primary outcomes

  1. Determine change from baseline in exercise capacity after Fontan stenting.

    Time frame: 1 year post enrollment

    Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.

  2. Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Moxness

CONTACT

[email protected]

3233619823

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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