First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 24
- 主要终点
- Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
研究概览
简要总结
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.
详细描述
Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Main Inclusion Criteria
- •Adults 18 years or older with heart failure with any of the following in the past 6 months: a decompensation due to heart failure resulting in a heart failure hospitalisation, heart failure treatment in a hospital day-care setting or urgent outpatient heart failure visit
- •Receiving treatment in accordance with internationally recognised guidelines.
- •Signed patient informed consent form
排除标准
- •Significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol
- •Patients with an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
- •Patients with IVC filter placement in situ, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC
- •Patients with implantable ventricular assist device (LVAD, RVAD, BiVAD) in situ
- •Patients with Cardiovascular Implantable Electronic Device (CIED) implanted ≤ 3 months prior to enrolment
- •Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins (e.g. venous leg ulcers)
研究组 & 干预措施
FIRE1 System
FIRE1 System
干预措施: FIRE1 System (Device)
结局指标
主要结局
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
时间窗: 3 months
The primary, composite endpoint is success of the FIRE1 sensor, which includes procedural success defined as sensor deployment at the intended site without acute device or procedural related complications and freedom from sensor complications including device migration, clinically significant fracture and/ or clinically significant perforation of the Inferior Vena Cava (IVC) or symptomatic caval thrombosis.
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor
时间窗: 3 months
Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.
次要结局
- Secondary Technical Endpoint - Successful transmission of FIRE1 signal.(3 months)
- Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound(3 months)