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Heart FailureNORM-HFNCT07574593

NORM-HF Pivotal Study

A study testing IVC Sensor in people with Heart Failure and NYHA Class III Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IVC Sensor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
25 sitesUnited States
Study dates
29 May 2026to Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • OR
  • 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.
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  • OR
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Any condition that, in the opinion of the Investigator, would not allow for implantation or utilization of IVC sensor.
  • Current or anticipated participation in any other clinical study during the duration of this study not pre-approved by the Sponsor.
  • Patients with active systemic infection at screening.
  • 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.
  • 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.
  • 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.
  • Patients who have procedures planned that require venous femoral access within 3 months of the Sensor implantation.
  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Troy Penz contact

+1 617-802-5911

NORM-HF@fire1foundry.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Cardiovascular Institute of the South

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Cardiovascular Institute of San Diego

    Chula Vista, California, 91911

    Recruiting

  • Christ Hospital Lindner

    Cincinnati, Ohio, 45219

    Recruiting

  • Ohio State University Hospital

    Colombus, Ohio, 43210

    Recruiting

  • Prisma Health - Midlands

    Columbia, South Carolina, 29203

    Recruiting

  • Baylor Scott & White - Dallas

    Dallas, Texas, 75246

    Recruiting

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

    Recruiting

  • University of Florida Health - Jacksonville

    Jacksonville, Florida, 32209

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • NYU Langone

    New York, New York, 10016

    Not yet recruiting

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

    Not yet recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Baylor Scott & White - Plano

    Plano, Texas, 75093

    Recruiting

  • Baylor Scott & White - Round Rock

    Round Rock, Texas, 78665

    Recruiting

  • UC Davis

    Sacramento, California, 95817

    Recruiting

  • North Central Heart - Avera Hospital

    Sioux Falls, South Dakota, 57108

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Recruiting

  • Baycare Health System

    Tampa, Florida, 33607

    Recruiting

  • Baylor Scott & White - Temple

    Temple, Texas, 76508

    Recruiting

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

    Recruiting

  • Saint Francis Health System

    Tulsa, Oklahoma, 74136

    Recruiting

Other trials in United States

About this study

Official title: 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).

Being tested
IVC Sensor
Keywords
FIRE1, NORM-HF, IVC Sensor, Remote Monitoring, Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVC SensorDevice

    Patients will be implanted with an inferior vena cava sensor

Study groups in NCT07574593
Study groupRoleWhat they receive
InterventionExperimentalimplant of the sensor, physician directed, patient self-management and guideline directed heart failure management
Receives: Device: IVC Sensor
ControlNo interventioncontrol arm - standard medical therapy with guideline directed heart failure management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC.

    Measured: Up to 5 years

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start29 May 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574593
Sponsor's protocol ID
TF05-CID01
Acronym
NORM-HF
Status last verified
Oct 2026
First submitted
28 Apr 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IVC Sensor in people with Heart Failure and NYHA Class III Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Troy Penz (+1 617-802-5911, NORM-HF@fire1foundry.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07574593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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