NCT07574593
NORM-HF Pivotal Study
Recruiting
NAAges 18+InterventionalPreventionFoundry Innovation & Research 1, Limited (FIRE1)
~800 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:IVC Sensor
At a glance
Recruiting sites
6 of 6 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
Where it's being run
6 sites across 5 statesFlorida2
California1
Ohio1
Oklahoma1
South Dakota1
Who to contact
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Do you actually qualify for this trial?
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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.