clinical trial · NCT07574593
NORM-HF Pivotal Study
Foundry Innovation & Research 1, Limited (FIRE1)·N/A·recruiting·n = 800
Heart FailureNYHA Class III Heart FailureNYHA Class II Heart FailureIVC Sensor
brief summary
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).
started
May 29, 2026
primary completion
Aug 1, 2029
completion
Dec 1, 2033
last updated
Jun 10, 2026
official title
NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol