NCT07073612 Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
| NCT ID | NCT07073612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Los Angeles |
| Condition | Single-ventricle |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Neil Patel, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT07073612 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Single-ventricle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07073612 currently recruiting?
Yes, NCT07073612 is actively recruiting participants. Contact the research team at mmoxness@chla.usc.edu for enrollment information.
Where is the NCT07073612 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07073612 clinical trial?
NCT07073612 is sponsored by Children's Hospital Los Angeles. The principal investigator is Neil Patel, MD at Children's Hospital Los Angeles. The trial plans to enroll 20 participants.