NORM-HF Pivotal Study

Study acronym: NORM-HF
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Lead sponsor: Foundry Innovation & Research 1, Limited (FIRE1) to Foundry Innovation & Research 1, Limited (FIRE1)
    • Trial sites expanded: 9 → 25 locations
    • Eligibility criteria expanded, about 34 words
  2. Study sites: 8 to 9v6
  3. Study sites: 6 to 8v5
  4. Trial sites expanded: 3 → 6 locationsv4
  5. Study sites: 2 to 3v3
  6. Recruitment opened
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2026 to May 29, 2026
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07574593
Lead Sponsor Foundry Innovation & Research 1, Limited (FIRE1)
Collaborators: NAMSA, Baim Institute for Clinical Research
Conditions
(from sponsor)		 Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure
Related terms Heart Failure
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov