Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT07073612

Conditions

Single-ventricle

Stenosis

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

Cardiopulmonary Exercise Testing (CPET)

Shear Wave Elastography Scan

Study Details

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

Study ID

NCT07073612

Start date

Aug 1, 2025

Status verified date

Jul, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort

Single ventricle fontan.

Interventions

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.

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.

Primary outcome measure

  • Determine change from baseline in exercise capacity after Fontan stenting. [ Time Frame: 1 year post enrollment ]
  • Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting. [ Time Frame: 1 year post enrollment ]

Central Contacts and Locations

Central contacts

Molly Moxness

3233619823mmoxness@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Molly Moxness

3233619823mmoxness@chla.usc.edu

Principal Investigator:

Neil Patel, MD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Keywords

  • Stent
  • fontan
  • Single-ventricle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-07-18.