Multicenter ECMO for Children: Cardiohelp System
Official title: Multicenter Trial of ECMO in Children with Severe Cardiac Failure using the Cardiohelp System
Funded at Boston Children's Hospital · NIH-11563784 · Data updated 2026-11-12
A multicenter study tests whether the Cardiohelp ECMO circuit can safely support children with severe heart failure for up to 30 days.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Boston Children's Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project start | September 15, 2023 |
| Project end | July 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $613,338 |
| NIH project number | 3R01FD007833-01A1S1 |
| Project ID | NIH-11563784 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children aged 0 to 16 years (3 to 80 kg) with severe cardiac failure requiring VA ECMO who have no other viable treatment options.
✕Less likely to help
Children not requiring VA ECMO or those with conditions likely unsuitable for ECMO may not benefit.
What this research studies
This study will involve five pediatric centers and enroll up to 50 children aged 0 to 16 years who need VA ECMO after other options have failed. Researchers will collect safety and effectiveness data on using the Cardiohelp system in pediatric patients to support circulation during critical illness. The goal is to gather information that could lead to FDA clearance of a complete pediatric ECMO circuit and improve treatment options for kids in life-threatening cardiac failure.
Why it matters
Potential benefit: If successful, the findings could lead to FDA clearance of a pediatric ECMO circuit and provide safer, more reliable support for children with severe heart failure.
How similar studies have gone: Previous studies suggest Cardiohelp can support pediatric patients with manageable complications, but an FDA-clearance pathway remains under review.
Where this research is happening
-
Boston Children's Hospital
Boston, United States Active
Researchers
- Principal investigator: Sleeper, Lynn a — Boston Children's Hospital
- Study coordinator: Sleeper, Lynn a
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Using the Cardiohelp System for life support in children with severe heart failure
This study is looking at a special heart support device called the Cardiohelp system to see how well it works and keeps kids safe when they have serious heart problems and other treatments haven't worked, and it's for children aged 0 to 16 who need extra help for their hearts.
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.