NCT07574593招募中不适用
NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
Foundry Innovation & Research 1, Limited (FIRE1)9 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年5月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 9
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
Experimental
implant of the sensor, physician directed, patient self-management and guideline directed heart failure management
干预措施: IVC Sensor (Device)
Control
No Intervention
control arm - standard medical therapy with guideline directed heart failure management
研究者
研究点 (9)
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