Cardiohelp Device for Severe Heart Failure in Children
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Recruiting
Phase 2
Interventional Study
Heart Failure
Cardiogenic Shock
Congenital Heart Disease
Cardiomyopathies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 16
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Stanford University · Other
Who this trial is looking for
This trial is looking for children with severe heart failure to test a device called Cardiohelp. Participants will receive support from this device and may be asked to use one of two different blood thinners during their care.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 0 and 16 years old.
- I weigh between 2.5 and 80 kilograms.
- I am receiving VA-ECMO for primary heart failure using the Cardiohelp system.
- This is my first ECMO run during this hospitalization.
- My parent or legal guardian has given written informed consent.
You may not be able to join if
- I was born prematurely and my corrected age is less than 37 weeks.
- I have bleeding issues that prevent me from using anticoagulants.
- I have irreversible failure of my kidneys, liver, or lungs.
- I had a stroke or am not sure about my neurological status within the last 30 days.
- I am severely malnourished.
- I am using an ECMO system other than Cardiohelp.
- I have goals that focus only on comfort measures.
- I cannot start randomization within 30 hours after ECMO cannulation.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:
1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.
2…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Age 0 to 16 years of age (i.e., \<17 years)
2. Body weight 2.5 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during the current hospitalization
5. Written informed consent from the parent or legally appointed represe…
Contacts