NORM-HF Pivotal Study

Официальное название

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

Обзор

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).

Вмешательства

• Устройство IVC Sensor
  Patients will be implanted with an inferior vena cava sensor

Первичные конечные точки

• The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC. [Срок оценки: Up to 5 years]
• The primary safety endpoint is freedom from a composite of clinical endpoints. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 6 центров

• Cardiovascular Institute of San Diego — Chula Vista
• University of Florida Health - Jacksonville — Jacksonville
• Baycare Health System — Tampa
• Christ Hospital Lindner — Cincinnati
• Saint Francis Health System — Tulsa
• North Central Heart - Avera Hospital — Sioux Falls

Идентификаторы

NCT: NCT07574593 · TF05-CID01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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