IVC Sensor for Heart Failure
(NORM-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Are You a Good Fit for This Trial?
This trial is for adults with moderate heart failure (NYHA class II or III) who have had a recent worsening of their condition, high NT-proBNP blood levels, and are on daily diuretics. Participants must be able to use internet at home and meet certain heart vein size requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the NORM™ System and guided heart failure management or standard of care with guided heart failure management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares the FIRE1 NORM System—a device that monitors heart function via an IVC sensor plus guided care—against standard heart failure treatment. Patients are randomly assigned to either group to see which approach better reduces hospitalizations and deaths from heart problems.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
implant of the sensor, physician directed, patient self-management and guideline directed heart failure management
control arm - standard medical therapy with guideline directed heart failure management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foundry Innovation & Research 1, Limited (FIRE1)
Lead Sponsor
NAMSA
Collaborator
Baim Institute for Clinical Research
Collaborator
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