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Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

NCT07073612 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-07-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Neil Patel, MD · Children's Hospital Los Angeles

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073612 on ClinicalTrials.gov