Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity (NCT07073612)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles โ Los Angeles, California
Age range: 12 Years to 21 Years
๐งช Interventions in This Study
- Cardiopulmonary Exercise Testing (CPET) (DIAGNOSTIC_TEST)
- Shear Wave Elastography Scan (DIAGNOSTIC_TEST)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Children's Hospital Los Angeles โ Los Angeles, California
๐ Contact the Study Coordinator
Phone: (323) 361-9823
Email: mmoxness@chla.usc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Fontan Fitness Trial โ Philadelphia, Pennsylvania
- Association of Near Infrared Spectroscopy With Interstage Outcomes โ Oak Lawn, Illinois
- Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology โ Corpus Christi, Texas
- Venous Compression in Fontan โ Dallas, Texas
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.