Condition: Heart Failure · NYHA Class III Heart Failure · NYHA Class II Heart Failure · Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
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).
This description comes directly from the study's public registry record.
Troy Penz · +1 617-802-5911 · NORM-HF@fire1foundry.com
Always discuss trial participation with your own doctor first.
| Cardiovascular Institute of San Diego | Chula Vista, California, United States | Recruiting |
| Saint Francis Health System | Tulsa, Oklahoma, United States | Recruiting |
| North Central Heart - Avera Hospital | Sioux Falls, South Dakota, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07574593