NORM-HF Pivotal Study
Sponsored by Foundry Innovation & Research 1, Limited (FIRE1)
About this study
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in a 1:1 ratio to receive either NORM™ System and guided heart failure management (intervention group) or usual standard of care with guided heart failure management (control group).
Enrolling at this location
University of Pennsylvania
Philadelphia, Pennsylvania
I'm interestedThis study also enrolls at 8 other locations. See all.
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Trial data sourced from ClinicalTrials.gov.