RECRUITING

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity

Quick Facts

Study Start:2025-08-01
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07073612

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.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization
  2. * Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis at the discretion of the primary operator
  3. * Weight ≥ 50 kg
  4. * 12-21 years of age
  1. * Interrupted IVC
  2. * Greater than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (RF \> 20%).
  3. * Greater than mild systemic ventricular dysfunction on most recent echo or MRI (EF \< 40%).
  4. * Non-sinus rhythm
  5. * Pacemaker
  6. * Inability to perform exercise test due to developmental or physical disability

Contacts and Locations

Study Contact

Molly Moxness
CONTACT
3233619823
mmoxness@chla.usc.edu

Principal Investigator

Neil Patel, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Hospital Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • Stent
  • fontan
  • Single-ventricle

Additional Relevant MeSH Terms

  • Single-ventricle
  • Stenosis