Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-21
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients 12-21 years old with functioning single-ventricle Fontan-palliated who are scheduled to undergo clinically indicated fontan conduit stenting.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Cardiopulmonary Exercise Testing (CPET)
Diagnostic testCPET 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 testThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cohort2 interventions
Trial outcomes
Primary outcomes
1
Determine change from baseline in exercise capacity after Fontan stenting.
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Time frame
1 year post enrollment2
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.
Time frame
1 year post enrollmentSponsors and contacts
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Source ClinicalTrials.gov