NCT01185691终止不适用
RELIEF I: Investigating the Role of IMPELLA 2.5 System In Acutely Decompensated Chronic Heart Failure Patients. A Prospective, Single Center Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Abiomed Inc.
- 入组人数
- 1
- 主要终点
- Major Adverse Events
研究概览
简要总结
The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria:
- •Chronic heart failure patients, hospitalized due to decompensated heart failure (ADHF) with NYHA Class III-IV symptoms (ADHF is defined by the presence of at least one of the following symptoms/signs: dyspnea w/orthopnea, jugular venous distension, peripheral edema +2, abdominal ascites, signs of CHF on chest X-Ray)
- •LVEF ≤ 40 % within the past 3 months
排除标准
- •Acute Q-wave myocardial infarction or Acute coronary syndrome within past 30 days
- •Cardiac surgery within the past 30 days
- •Implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization
结局指标
主要结局
Major Adverse Events
时间窗: 30 day or discharge(whichever is longer)
次要结局
未报告次要终点
研究者
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