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No phaseRecruiting

NORM-HF Pivotal Study

Sponsor
Foundry Innovation & Research 1, Limited (FIRE1) (Industry)
Enrolment
800 planned
Conditions
Heart Failure; NYHA Class III Heart Failure; NYHA Class II Heart Failure
Interventions
IVC Sensor
Ages
adults, older adults
Registry
NCT07574593

Full record on ClinicalTrials.gov

From the registry

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).

Primary outcomes

  • The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC.
  • The primary safety endpoint is freedom from a composite of clinical endpoints.

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered