Clinical Trial

NORM-HF Pivotal Study

Study acronym: NORM-HF
Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 2 changes
notable Trial sites expanded: 3 -> 6 locations 2026-08-01
critical Recruitment opened 2026-06-11
Trial Details
NCT Number NCT07574593
Lead Sponsor Foundry Innovation & Research 1, Limited (FIRE1)
Collaborators: NAMSA, Baim Institute for Clinical Research
Conditions Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure
Enrollment 800 participants
Start Date 2026-05-29
Primary Completion 2029-08 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10