Single-ventricleNCT07073612
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
An observational study of Single-ventricle and Stenosis, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Single-ventricle, Stenosis
- What is being tested?
- Cardiopulmonary Exercise Testing (CPET) and Shear Wave Elastography Scan
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Child, Adult
Study population: Patients 12-21 years old with functioning single-ventricle Fontan-palliated who are scheduled to undergo clinically indicated fontan conduit stenting.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Molly Moxness, 3233619823, mmoxness@chla.usc.edu
Neil Patel, MD
About this study
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.
- Conditions
- Single-ventricle, Stenosis
- Being tested
- Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan
- Keywords
- Stent, fontan, Single-ventricle
- Medical subject headings
- Univentricular Heart, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise Testing (CPET)Diagnostic test
CPET will be performed on a cycle ergometer using a ramp protocol designed to achieve an exercise time of 8-12 min. The entire procedure duration is approximately 60 min. CPET will be completed 6 months to 1 day before the cardiac catheterization and will be repeated 3-6 months following cardiac catheterization.
Shear Wave Elastography ScanDiagnostic test
The study lasts approximately 20 minutes. Shear Wave Elastography will be completed 6 months to 1 day before the cardiac catheterization. The Scan will be repeated 2-4 weeks following cardiac catheterization, and 3-6 months following cardiac catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Single ventricle fontan. Receives: Diagnostic Test: Cardiopulmonary Exercise Testing (CPET); Diagnostic Test: Shear Wave Elastography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine change from baseline in exercise capacity after Fontan stenting.
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Measured: 1 year post enrollment
Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting.
FibroScan will be used to assess liver stiffness before catheterization, at 2-4 weeks following stent placement, and 3-6 months following stent placement.
Measured: 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Patel, Children's Hospital Los Angeles
- Investigators
- Neil Patel, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073612
- Sponsor's protocol ID
- CHLA-25-00052
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
- ClinicalTrials.gov ID
- NCT07073612
- Acronym / sponsor ID
- CHLA-25-00052
- Conditions
- Single-ventricle, Stenosis
- Keywords
- Stent, fontan, Single-ventricle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: Cardiopulmonary Exercise Testing (CPET), Diagnostic Test: Shear Wave Elastography ScanSingle ventricle fontan. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients 12-21 years old with functioning single-ventricle Fontan-palliated who are scheduled to undergo clinically indicated fontan conduit stenting.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Exercise Testing (CPET)CPET will be performed on a cycle ergometer using a ramp protocol designed to achieve an exercise time of 8-12 min. The entire procedure duration is approximately 60 min. CPET will be completed 6 months to 1 day before the cardiac catheterization and will be repeated 3-6 months following cardiac catheterization. | Diagnostic test | Cohort |
| Shear Wave Elastography ScanThe study lasts approximately 20 minutes. Shear Wave Elastography will be completed 6 months to 1 day before the cardiac catheterization. The Scan will be repeated 2-4 weeks following cardiac catheterization, and 3-6 months following cardiac catheterization. | Diagnostic test | Cohort |
Primary outcome
Determine change from baseline in exercise capacity after Fontan stenting.
Time frame: 1 year post enrollment
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting.
Time frame: 1 year post enrollment
FibroScan will be used to assess liver stiffness before catheterization, at 2-4 weeks following stent placement, and 3-6 months following stent placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Patel, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single-ventricle and Stenosis, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Moxness (3233619823, mmoxness@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine change from baseline in exercise capacity after Fontan stenting. (time frame: 1 year post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.