Using the Cardiohelp System for life support in children with severe heart failure
Multicenter Trial of ECMO in Children with Severe Cardiac Failure using the Cardiohelp System
['FUNDING_R01'] · BOSTON CHILDREN'S HOSPITAL · NIH-10861648
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
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | BOSTON CHILDREN'S HOSPITAL (nih funded) |
| Locations | 1 site (BOSTON, UNITED STATES) |
| Trial ID | NIH-10861648 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Ideal candidates for this research are children aged 0 to 16 years who are experiencing severe cardiac failure and require emergent life support.
Not a fit: 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.
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 performed: 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, UNITED STATES
- BOSTON CHILDREN'S HOSPITAL — BOSTON, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SLEEPER, LYNN A — BOSTON CHILDREN'S HOSPITAL
- Study coordinator: SLEEPER, LYNN A
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 below.