Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
NCT ID: NCT07073612
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-08-01
2027-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cohort
Single ventricle fontan.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
21 Years
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
Responsible Party
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Neil Patel
Medical Staff/USC Faculty CWR • Cardiology CWR
Principal Investigators
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Neil Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHLA-25-00052
Identifier Type: -
Identifier Source: org_study_id
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