Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT07073612
Status
Recruiting
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Conditions

  • Single-ventricle
  • Stenosis

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Cohort
    Single ventricle fontan.

Primary Outcome Measure

Determine change from baseline in exercise capacity after Fontan stenting. [ Time Frame: 1 year post enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Molly Moxness
[email protected]
3233619823
Neil Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles· Los Angeles, CA

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