An observational study in Single-ventricle and Stenosis, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Children's Hospital Los Angeles · Observational
Among 55 studies in Univentricular Heart with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Univentricular Heart · United States.
Among the 55 studies in Univentricular Heart with a site in United States, this one is the 16th largest by planned enrollment of the 23 observational ones that give a count, is one of 3 that started in 2025, is one of 23 observational ones, reaches primary completion later than 9 of the 15 other live ones, and was the 52nd registered.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
Browse Univentricular Heart studies →13 of the 55 studies in Univentricular Heart with a site in United States are open now. Recruiting first, the newest first:
Le Bonheur Children's Hospital · Sites in United States
Ages 0 mo–12 mo
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–45 · Healthy volunteers
Driscoll Children's Hospital · Sites in United States
Ages 0 mo–6 mo
Children's Hospital of Philadelphia · Sites in United States
Ages 10–17
Boston Children's Hospital · Sites in United States
Ages 1 days–7 days
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Univentricular Heart studies recruiting now, 8 (38%) set no upper age limit and 13 (62%) stop at 75 or younger; 16 take children under 18; 1 takes healthy volunteers.
This study: 12 Years to 21 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 2
First in 2000; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 42 across 37 observational studies indexed under Univentricular Heart.
Median enrollment 24 across the 32 interventional studies, 30 across the 23 observational. Of the 36 that completed or were terminated, 12 (33%) have results posted.
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2 of 55 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Children's Hospital Los Angeles has 1 study filed under Univentricular Heart — fewer than ten, so there is no comparison to draw.
5 of the studies in Univentricular Heart with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT06150950Stanford UniversityREHAB Fontan Failure: A Trial of Cardiac Rehabilitation | 2026-12-31 |
| NCT05262907Duke UniversityVentripoint Single Ventricle Study | 2027-08 |
| NCT05647213HeartWorks, Inc.Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease | 2027-09 |
| NCT07220226University of Texas Southwestern Medical CenterVenous Compression in Fontan | 2027-11-01 |
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Among the 55 studies in Univentricular Heart with a site in United States, from their registry updates:
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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.
Patients 12-21 years old with functioning single-ventricle Fontan-palliated who are scheduled to undergo clinically indicated fontan conduit stenting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Single ventricle fontan.
Diagnostic Test: Cardiopulmonary Exercise Testing (CPET) · Diagnostic Test: Shear Wave Elastography Scan
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.
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.
Determine change from baseline in exercise capacity after Fontan stenting.
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Time frame: 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.
Time frame: 1 year post enrollment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Dec 2027, 28 months later.
How these figures are worked out, and which studies are left out of them.
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Children's Hospital Los Angeles →