Current Research Studies
Multicenter Trial of ECMO For Children with Severe Cardiac Failure using the Cardiohelp System
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What is the goal of the study?
The purpose of the study is to evaluate the safety and effectiveness of the Cardiohelp Device for up to 30 days of support in children with severe cardiac failure where the risk of death is imminent. We have designed this study with the FDA to collect fundamental safety and effectiveness data on the Cardiohelp system, one of the most common ECMO circuits used in children. Data from this study will be used to obtain FDA clearance of the very first standalone ECMO circuit in pediatrics and to characterize its optimal performance specifications in infants and children which will be summarized in the FDA label/IFU to guide safe clinical use.
Who can participate in the study?
Please contact the study team listed below to learn more.