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NORM-HF Pivotal Study

NCT07574593 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-05-08

No results posted yet for this study

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).

Conditions

  • Heart Failure
  • NYHA Class III Heart Failure
  • NYHA Class II Heart Failure

Interventions

DEVICE

IVC Sensor

Patients will be implanted with an inferior vena cava sensor

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Foundry Innovation & Research 1, Limited (FIRE1)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-08-31
Completion
2033-12-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574593 on ClinicalTrials.gov