NORM-HF Pivotal Study (NORM-HF)

NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; NYHA Class III Heart Failure; NYHA Class II Heart Failure
• Intervention / Treatment: Device: IVC Sensor

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Troy Penz; Phone Number: +1 617-802-5911; Email: NORM-HF@fire1foundry.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

1. Adults 18 years of age or older.
2. Provide informed consent for participation in the clinical study and be willing and able to comply with the required assessments, treatment instructions, and clinical follow-up visits according to the specified schedule.

3. Patients meeting diagnostic criteria for HF diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC/HFSA or ESC HF guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidenced by meeting either 3a, 3b OR 3c criterion below:

   1. NYHA functional class II with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL. For those patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.

      OR

   2. NYHA functional class III with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥ 600 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-pro BNP ≥900 pg/mL.

      OR

   3. NYHA functional class III AND NT-proBNP ≥1000 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.
4. Patients must be prescribed a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the two weeks prior to screening.
5. Patients must be able to have their daily dose of loop diuretic be increased by at least 1.5 times.
6. IVC diameter within the landing zone of between 14mm and 28mm.
7. Minimum IVC landing zone length of 60 mm.
8. Patients have sufficient cellular and/or Wi-Fi Internet coverage at home and can access the internet on a phone or a computer at home.

EXCLUSION CRITERIA

1. Presence of advanced end stage HF, suggested by but not limited to:

   • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; implant of the sensor, physician directed, patient self-management and guideline directed heart failure management	Device: IVC Sensor; Patients will be implanted with an inferior vena cava sensor
No Intervention: Control; control arm - standard medical therapy with guideline directed heart failure management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months

Collaborators and Investigators

• Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
• Collaborators: NAMSA; Baim Institute for Clinical Research

Publications and helpful links

Helpful Links

• FIRE1 website

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Remote Monitoring; FIRE1; NORM-HF; IVC Sensor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: TF05-CID01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes