NORM-HF Pivotal Study

Part of paid clinical trials in Chula Vista, California.

Sponsor
Foundry Innovation & Research 1, Limited (FIRE1)
Study ID
NCT07574593
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IVC Sensor — DEVICE
    Patients will be implanted with an inferior vena cava sensor

Study Details

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).

Key Dates

First listed
May 8, 2026
Start date
May 29, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Dec 31, 2033

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    implant of the sensor, physician directed, patient self-management and guideline directed heart failure management
  • No Intervention: Control
    control arm - standard medical therapy with guideline directed heart failure management

Primary Outcome Measure

The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC. [ Time Frame: Up to 5 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Cardiovascular Institute of San DiegoChula VistaCalifornia91911-
UC DavisSacramentoCalifornia95817-
University of Florida Health - JacksonvilleJacksonvilleFlorida32209-
Baycare Health SystemTampaFlorida33607-
Columbia University Irving Medical Center/ New York Presbyterian HospitalNew YorkNew York10032-
Christ Hospital LindnerCincinnatiOhio45219-
Saint Francis Health SystemTulsaOklahoma74136-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
North Central Heart - Avera HospitalSioux FallsSouth Dakota57108-

Find similar trials in Chula Vista, CA

Nationwide
Heart failure trialsCardiology trialsHeart disease trials
By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cardiovascular Institute of San Diego· Chula Vista, CAUC Davis· Sacramento, CAUniversity of Florida Health - Jacksonville· Jacksonville, FLBaycare Health System· Tampa, FLColumbia University Irving Medical Center/ New York Presbyterian Hospital· New York, NYChrist Hospital Lindner· Cincinnati, OH

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