RECRUITING

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Description

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.

Study Overview

Study Details

Study overview

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.

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Condition
Single-ventricle
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Pacemaker
  • * Inability to perform exercise test due to developmental or physical disability

Ages Eligible for Study

12 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Los Angeles,

Neil Patel, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

2027-12-01