A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 21
- 主要终点
- Change in NT-proBNP blood test levels
研究概览
简要总结
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.
详细描述
Subjects presenting with Class II, III or ambulatory IV heart failure with a left ventricular ejection fraction of ≤ 40% and NT-proBNP ≥ 400 will be considered for the study. Subjects who meet the initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD device. Eligible subjects will receive an implant placed in the internal carotid artery.
Following implantation of the device, subjects will be seen at 1 week, 1, 3, 6, 12, 18, and 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
- Treatment
- 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
- •Age 18 years or above
- •Currently NYHA Class II, III or ambulatory IV heart failure
- •Left ventricular ejection fraction ≤ 40%
- •NT-proBNP ≥ 400
- •Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
- •Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
- •Deemed an acceptable candidate for the implant procedure by the investigator
排除标准
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
- •Currently implanted with a barostimulator device
- •Received cardiac resynchronization therapy (CRT) within six months of implantation
- •Received a CardioMEMS device within three months of the screening visit
- •History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
- •Body mass index > 45
- •Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- •Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
- •Internal ICA lumen diameters <5.0 mm or >11.75 mm within the planned location of the implant placement, or evidence of landing zone restrictions, such as inadequate length, vessel tapering, and/or vessel curvature that would preclude safe placement of the implant
结局指标
主要结局
Change in NT-proBNP blood test levels
时间窗: 24 months
Change in Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months
Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
时间窗: 24 months
Change in QoL measures between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months will be measured. The KCCQ is used to measure the effect of heart failure on quality of life with a lower score indicating a worsening quality of life. The EQ-5D Questionnaire is a general measure of overall health with a lower score indicating a better overall health perception.
Change in cardiac function / structure
时间窗: 24 months
Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
Cardiovascular Mortality
时间窗: 24 months
Rate of cardiovascular mortality throughout the follow-up period will be reported.
Change in 6MHW distance
时间窗: 24 months
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Adverse Events
时间窗: 24 months
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Heart Failure Hospitalizations
时间窗: 24 months
Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Change in New York Heart Association Heart Failure Class
时间窗: 24 months
Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
次要结局
未报告次要终点