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
Qualifiers
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 design
Treatments tested in this trial
- Cardiopulmonary Exercise Testing (CPET)
- Shear Wave Elastography Scan
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov