Using the Cardiohelp System for life support in children with severe heart failure
Official title: Multicenter Trial of ECMO in Children with Severe Cardiac Failure using the Cardiohelp System
Funded at Boston Children's Hospital · NIH-10861648 · Data updated 2026-11-12
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.
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, 2028 |
| Funding year | 2023 |
| Award (this year) | $608,916 |
| NIH project number | 1R01FD007833-01A1 |
| Project ID | NIH-10861648 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are children aged 0 to 16 years who are experiencing severe cardiac failure and require emergent life support.
✕Less likely to help
Patients who do not have severe cardiac failure or are outside the age range of 0 to 16 years may not benefit from this research.
What this research studies
This research investigates the use of the Cardiohelp system, a device designed to provide life support for children experiencing severe cardiac failure. The study aims to evaluate the safety and effectiveness of this system in supporting children for up to 30 days when other treatment options have failed. Conducted across five specialized centers, the trial will involve 50 children aged 0 to 16 years who require venoarterial (VA) ECMO. The ultimate goal is to gather data that will support FDA clearance of this ECMO circuit specifically for pediatric use.
Why it matters
Potential benefit: If successful, this research could lead to the first FDA-approved ECMO circuit for children, significantly improving treatment options for severe cardiac failure.
How similar studies have gone: Previous studies have shown promising results with the Cardiohelp system in pediatric patients, indicating potential for success in this trial.
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
Related research
Other NIH-funded projects on the same topics.
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Multicenter ECMO for Children: Cardiohelp System
A multicenter study tests whether the Cardiohelp ECMO circuit can safely support children with severe heart failure for up to 30 days.
-
A wearable monitor to detect worsening heart failure
This project is creating a new wearable device to help heart failure patients and their doctors spot early signs of worsening heart failure from home.
-
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This study is testing a new wearable device that helps people with heart failure by spotting early signs of worsening health, so doctors can step in sooner and keep them out of the hospital.
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Investigating how DNA changes affect heart failure and recovery
This study is looking at how changes in DNA might affect heart recovery for people with heart failure who are using special devices to help their hearts pump better, and it invites patients to share their information to help find new ways to improve heart health.
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Heart remodeling after endovascular aortic repair
We will see if endovascular aortic repair changes heart size, shape, or function in adults treated for aortic aneurysms or related aortic problems.
-
Platelet population changes during ECMO circulatory support
This will test whether the proportions of different platelet types change during ECMO in adults with cardiac or respiratory failure.
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.