Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Launched by STANFORD UNIVERSITY · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the Cardiohelp System, which is used for a treatment called VA-ECMO in children who have severe heart failure. The main goal is to see how well this device works in helping children recover and whether it is safe to use. Researchers will also be looking at how the device performs in young patients compared to established standards from previous studies.

Children aged 0 to 16 years and weighing between 3 to 80 kilograms who are experiencing serious heart problems may be eligible to participate. Before they join, parents or guardians will be asked to give their permission. Participants will be monitored closely for 30 days to track their recovery and any serious side effects, such as bleeding or stroke. It’s important to know that this trial is not currently recruiting participants, so those interested will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 0 to 16 years of age
• • 2. Body weight 3 to 80 kilograms
• • 3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
• • 4. First ECMO run during any hospitalization
• • 5. Written informed consent from the parent or legally authorized representative.
• Exclusion Criteria:Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:
• • 1. Gestational Age \<37 weeks
• • 2. Bleeding or coagulopathy that is a contraindication to anticoagulation
• • 3. Irreversible renal, hepatic or lung failure
• • 4. Stroke or uncertain neurological status within the past 30 days
• • 5. Severely malnourished
• • 6. Use of an ECMO system other than the Cardiohelp
• • 7. VV-ECMO or ECMO for primary respiratory failure
• • 8. Goals of patient to focus on comfort measures only.
• • 9. Failure to separate from cardiopulmonary bypass