Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

NCT07073612 | Recruiting

• 1 other identifier: CHLA-25-00052
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Single-ventricle; Stenosis

Keywords

Stent; fontan; Single-ventricle

Outcome Measures

Primary Outcomes (2)

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

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

  1 year post enrollment

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

  FibroScan will be used to assess liver stiffness before catheterization, at 2-4 weeks following stent placement, and 3-6 months following stent placement.

  1 year post enrollment

Study Arms (1)

Cohort

Single ventricle fontan.

Diagnostic Test: Cardiopulmonary Exercise Testing (CPET); Diagnostic Test: Shear Wave Elastography Scan

Interventions

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.

Cohort

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.

Cohort

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients 12-21 years old with functioning single-ventricle Fontan-palliated who are scheduled to undergo clinically indicated fontan conduit stenting.

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Univentricular Heart; Constriction, Pathologic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Neil Patel, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Moxness

CONTACT

3233619823; mmoxness@chla.usc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR • Cardiology CWR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)