NORM-HF Pivotal Study

NCT07574593 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TF05-CID01
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

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

Keywords

FIRE1; NORM-HF; IVC Sensor; Remote Monitoring; Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

implant of the sensor, physician directed, patient self-management and guideline directed heart failure management

Device: IVC Sensor

Control

NO INTERVENTION

control arm - standard medical therapy with guideline directed heart failure management

Interventions

IVC Sensor DEVICE

Patients will be implanted with an inferior vena cava sensor

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older.
• 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.
• 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:
• 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.
• 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.
• NYHA functional class III AND NT-proBNP ≥1000 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.
• Patients must be prescribed a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the two weeks prior to screening.
• Patients must be able to have their daily dose of loop diuretic be increased by at least 1.5 times.
• IVC diameter within the landing zone of between 14mm and 28mm.
• Minimum IVC landing zone length of 60 mm.
• 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.

You may not qualify if:

• 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.
• Severe right sided valvular disease or a right sided mechanical valve.
• Patients with abdominal circumference of greater than 143 cm (56 inches) at screening.
• Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 mL/min/1.73m2 or receiving ultrafiltration or chronic dialysis.
• 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.
• Significant congenital heart disease that would impair ability to implant the IVC sensor or complicate interpretation of the reading (e.g., fontan circulation physiology).
• 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.
• 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.
• Implanted or planned implantation of a pulmonary artery pressure (PAP) monitor.
• Patients that are pregnant, nursing or planning a pregnancy within 1 year of screening.
• Anticipated life expectancy \< 12 months due to another etiology or severity of HF.

Sponsors & Collaborators

• Foundry Innovation & Research 1, Limited (FIRE1): lead
• NAMSA: collaborator
• Baim Institute for Clinical Research: collaborator

Related Links

• FIRE1 website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Troy Penz

CONTACT

+1 617-802-5911; NORM-HF@fire1foundry.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share