Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 60
- 试验地点
- 34
- 主要终点
- Freedom from Major Adverse Events through 90 days post-discharge.
研究概览
简要总结
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
详细描述
The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.
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
- •NYHA Class III-IV heart failure
- •Subjects with inadequate diuresis
- •Stage C-D systolic heart failure
排除标准
- •Active myocardial ischemia or acute coronary syndrome (ACS)
- •Severe aortic or mitral valve insufficiency
- •Severe peripheral vascular disease
结局指标
主要结局
Freedom from Major Adverse Events through 90 days post-discharge.
时间窗: 90 days post-discharge
MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.
次要结局
未报告次要终点