Status:
ENROLLING_BY_INVITATION
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Boston Children's Hospital
Duke University
Conditions:
Heart Failure
Cardiogenic Shock
Eligibility:
All Genders
Up to 16 years
Phase:
NA
Brief Summary
The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question\[s\] it a...
Detailed Description
This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure. Despite more than 50 years ...
Eligibility Criteria
Inclusion
- Age 0 to 16 years of age
- Body weight 3 to 80 kilograms
- VA-ECMO use for primary cardiac failure using the Cardiohelp system.
- First ECMO run during the current hospitalization
Exclusion
- Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:
- Gestationally-corrected Age \<37 weeks
- Bleeding or coagulopathy that is a contraindication to anticoagulation
- Irreversible renal, hepatic or lung failure
- Stroke or uncertain neurological status within the past 30 days
- Severely malnourished
- Use of an ECMO system other than the Cardiohelp
- VV-ECMO or ECMO for primary respiratory failure
- Goals of patient to focus on comfort measures only.
- Failure to separate from cardiopulmonary bypass
- Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.
- Patients who are pregnant or breastfeeding.
- Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06080074
Start Date
April 15 2025
End Date
September 1 2027
Last Update
November 10 2025
Active Locations (5)
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1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
2
Cuimc/Nyph
New York, New York, United States, 10032
3
Duke University Hospital
Durham, North Carolina, United States, 27710
4
Children's Health Dallas
Dallas, Texas, United States, 95235