RecruitingNot applicable

NORM-HF Pivotal Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the FIRE1 NORM System can reduce worsening heart failure and deaths from heart or blood vessel problems compared with usual care. It is for adults with heart failure that limits daily activity mildly or clearly (Class II or III). People are assigned by chance to either group, and both groups get guided heart failure care.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Agree to join and be willing and able to follow study care, tests, and visits.
  • Have heart failure for more than 90 days and take the best heart failure medicines you can tolerate for at least 30 days.
  • Have Class II or III heart failure and meet the required NT-proBNP blood test level, a sign of heart strain. The level depends on your symptoms, heart rhythm, and recent care for worsening heart failure. Class II always requires such care within the past 12 months.
  • Take at least 40 mg of furosemide daily, or an equal dose of a similar water pill, for the 2 weeks before screening.
  • Be able to increase your daily water pill dose to at least 1.5 times your current dose.
  • Have enough space for the sensor in the inferior vena cava (IVC), a large vein that returns blood to the heart: 14–28 mm wide and at least 60 mm long.
  • Have reliable cell service or Wi-Fi at home and internet access on a phone or computer.

Who can't join

  • Have advanced, end-stage heart failure; severe right-sided heart valve disease; a right-sided mechanical valve; certain serious heart muscle or heart sac diseases; or a heart defect present at birth that affects sensor use.
  • Have very poor kidney function (eGFR below 25), receive dialysis or blood filtering to remove fluid, or have a belly measurement over 143 cm (56 inches).
  • Had a major heart or blood vessel event, such as a heart attack, heart procedure, or stroke, within 90 days before consent. Certain heart failure devices placed during that time also rule you out. A lung artery pressure monitor, already placed or planned, rules you out.
  • Are pregnant, breastfeeding, or planning pregnancy within 1 year of screening; are expected to live less than 12 months; or have an active infection affecting the body.
  • Have an allergy to required medicines, sensor materials, or contrast dye that cannot be managed under the site's allergy plan. You also must be able to take two anti-clotting medicines for at least 30 days after placement and continue any prescribed oral blood thinner.
  • Have an IVC filter, certain abnormal or missing veins, or certain clots in the large belly or groin veins. A planned procedure needing access through a groin vein within 3 months of sensor placement also rules you out.
  • Had a blood clot in a vein or lung, or a clot that traveled through the blood, within 6 months before screening; or have ongoing concerns about blood clotting too easily.
  • Have another condition that prevents sensor placement or use, or take part in another study during this study without the sponsor's approval.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (25)

CA

FL

LA

MA

MO

NC

NE

NY

OH

OK

PA

SC

SD

TX