ACTION and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation.
ACTION, in conjunction with Berlin Heart, Inc., launched the first prospective FDA regulated device trial using a pediatric ventricular assist device (VAD) registry in November 2022. Enrollment in the trial has been completed as of August 11, 2023, just 10 months after launch.
The ACTION registry is being used to conduct prospective trials. Currently the Berlin Active Driver is being studied at 20 ACTION sites.
Prospective Trials Using a Registry as the Platform Read More »
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