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

Study Overview
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Brief Summary
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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 aims to answer are: What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. Outcomes will be compared to performance goals (PG) derived from the ECMO literature.

Detailed Description
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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 of use and significant mortality, no standalone ECMO device has ever been FDA-cleared for ECMO. All ECMO use in children is off-label and this may explain why there is significant center-based variation in ECMO use that is not evidence driven. This study seeks to change that by collecting systematic safety and effectiveness data on a single standardized ECMO circuit (Cardiohelp Device). The goal is to provide the data necessary to secure FDA clearance of the first pediatric ECMO system, to determine the optimal performance range of the Cardiohelp device in infants and children, and to provide the FDA with a predicate device to support FDA clearance of other ECMO systems.

Official Title
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Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure

Conditions
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Heart Failure, Cardiogenic Shock, Congenital Heart Disease, Cardiomyopathies

Intervention / Treatment
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* Device: Cardiohelp device (VA-ECMO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 any hospitalization 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: Gestational 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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiohelp device (VA-ECMO)|In children receiving the Cardiohelp device for severe heart failure, participants will be consented to a systematic data collection to describe the safety and effectiveness of the device in children.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke-free survival to 30 days, recovery, ventricular assist device implant or transplant. | Survival in the absence of symptomatic stroke to 30 days or decannulation for recovery, transplant or VAD implant | 30 days | 
| Symptomatic stroke | symptomatic stroke | 30 days | 
| Severe hemolysis | Severe hemolysis | 30 days | 
| Circuit change due to thrombus | ECMO circuit change due to thrombus | 30 days | 
| Major device malfunction | major device malfunction of the ECMO circuit | 30 days | 
| Renal failure | renal failure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all serious adverse events | Incidence rate of all serious adverse events (per day of support) | 30 days |