The V-Wave Shunt For 'Left Atrial Decompression' In Patients With Advanced Chronic Heart Failure: FIM Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation
研究概览
简要总结
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.
详细描述
V-Wave Ltd, an Israeli based medical device company, has developed the V-Wave atrial-septal shunt, a permanent implant indicated for Heart Failure (HF) patients with elevated Left Atrial filling Pressures (LAP). The V-Wave shunt, developed by V-Wave Ltd, has been designed specifically to meet the needs of an interatrial shunt and thus represents a dedicated device, to be implanted percutaneously in the interatrial septum creating an interatrial communication.
This study aims to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Heart Failure patients with elevated LAP. Study endpoints were then chosen to portray both safety (device related Major Adverse Cardiac And Neurological Events) as well as preliminary performance as assessed by a well characterized measure (e.g., LAP which is known to be associated with the general state of the disease and most importantly left ventricular ejection fraction and cardiac function in general).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 and < 85 years old
- •Patient has chronic ischemic or non-ischemic cardiomyopathy NYHA Class III or ambulatory Class IV heart failure despite optimal medical therapy
- •Patient LVEF > 15% and ≤ 40%
- •Patient has elevated Left Atrial Pressure (LAP)
- •Patient has normal Right Atrial Pressure (RAP)
- •BNP or NTproBNP levels are >300 or >1500 pg/mL, respectively
排除标准
- •Right Heart Failure
- •Ongoing malignant disease
- •Thromboembolic event within the last 6 months
- •Acute or chronic renal insufficiency
- •Congenital heart disease
- •Severe pulmonary hypertension
- •Atrial Fibrillation (persistent/permanent)
- •Severe Mitral Regurgitation
- •LA Thrombus or Deep Vein Thrombosis (DVT)
- •Severe restrictive or obstructive lung disease
研究组 & 干预措施
V-Wave shunt implant
Implantation of the V-Wave inter-atrial shunt
干预措施: Implantation of the V-Wave inter-atrial shunt (Device)
结局指标
主要结局
Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation
时间窗: 3 month
MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
次要结局
- Reduction in Pulmonary Capillary Wedge Pressure (PCWP)(3 and 12 month)
- Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation(12 month)