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NCT07574593

NORM-HF Pivotal Study

Recruiting
NAAges 18+InterventionalPrevention
Foundry Innovation & Research 1, Limited (FIRE1)
~800 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:IVC Sensor

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC.
Measured over Up to 5 years
+1 more outcome measured

Conditions

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

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NCT07574593

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baycare Health System

    Tampa, Floridano site contact published

    Recruiting

  • Cardiovascular Institute of San Diego

    Chula Vista, Californiano site contact published

    Recruiting

  • Christ Hospital Lindner

    Cincinnati, Ohiono site contact published

    Recruiting

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New Yorkno site contact published

    Not yet recruiting

  • North Central Heart - Avera Hospital

    Sioux Falls, South Dakotano site contact published

    Recruiting

  • Saint Francis Health System

    Tulsa, Oklahomano site contact published

    Recruiting

  • UC Davis

    Sacramento, Californiano site contact published

    Recruiting

  • University of Florida Health - Jacksonville

    Jacksonville, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Troy Penz
[email protected]
+1 617-802-5911
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Persistent NYHA functional class IV HF (ACC/AHA/ESC).
Current treatment with intravenous vasopressors or inotropes.
Received, or are likely to receive in the next 6 months, an advanced therapy (e.g., mechanical circulatory support or cardiac transplant or previously listed for transplant).
Receiving end of life HF care. 2. Severe right sided valvular disease or a right sided mechanical valve. 3. Patients with abdominal circumference of greater than 143 cm (56 inches) at screening. 4. Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 mL/min/1.73m2 or receiving ultrafiltration or chronic dialysis. 5. Presence of end stage hypertrophic cardiomyopathy, end stage restrictive cardiomyopathy, end stage pericardial constriction, end stage cardiac amyloidosis, or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis. 6. Significant congenital heart disease that would impair ability to implant the IVC sensor or complicate interpretation of the reading (e.g., fontan circulation physiology). 7. Major non-heart-failure-related CV event (i.e., unstable angina, Type 1 myocardial infarction (MI), percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent. 8. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P), CRT Defibrillator (CRT-D), Cardiac Contractility Modulation (CCM), or implantable neuromodulation devices used to treat HF symptoms within 90 days prior to consent. 9. Implanted or planned implantation of a pulmonary artery pressure (PAP) monitor. 10. Patients that are pregnant, nursing or planning a pregnancy within 1 year of screening. 11. Anticipated life expectancy \< 12 months due to another etiology or severity of HF. 12. Any condition that, in the opinion of the Investigator, would not allow for implantation or utilization of IVC sensor. 13. Current or anticipated participation in any other clinical study during the duration of this study not pre-approved by the Sponsor. 14. Patients with active systemic infection at screening. 15. Patients with hypersensitivity or allergy to antiplatelet agents or Sensor components (Nitinol, Polyurethane \[PU\], Nylon, Polyethylene Terephthalate \[PET\], and Gold) or contrast media that will not be managed with a clinical site-specific allergy protocol. 16. Unable to tolerate dual antiplatelet therapy for at least 30 days following implant of the respective sensor or unable to continue oral anticoagulation if currently prescribed. 17. Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy, known congenital malformation or absence of IVC, or occlusive or free-floating thrombus in the IVC, iliac, or common femoral veins. 18. Patients who have procedures planned that require venous femoral access within 3 months of the Sensor implantation. 19. Patients with pulmonary embolism, venous thrombosis, or thromboembolism in the 6 months prior to screening and/or with ongoing concerns of hypercoagulability due to underlying conditions e.g., thrombophilia.

What this trial measures

  • The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC.Up to 5 years
  • The primary safety endpoint is freedom from a composite of clinical endpoints.12 months

    Including freedom from procedure-related and sensor-related SAEs and serious complications including clinically significant perforation of the IVC, symptomatic caval thrombosis, or device embolization after the device implantation as adjudicated by an independent CEC and core imaging laboratory.