NCT05820451招募中不适用
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Abiomed Inc.
- 入组人数
- 330
- 主要终点
- Primary Endpoint Right Sided Impella
研究概览
简要总结
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left-sided Impella with bicarbonate in the purge
排除标准
- •Known LV thrombus
- •Right Sided Impella
- •Inclusion Criteria:
- •Right-sided Impella with bicarbonate in the purge
- •Exclusion Criteria:
- •Known pulmonary thromboemboli
- •Known DVT
结局指标
主要结局
Primary Endpoint Right Sided Impella
时间窗: From hospital admission until hospital discharge, average 5 days
Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)
Primary Endpoint Left Sided Impella
时间窗: From hospital admission until hospital discharge, average 5 days
Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
次要结局
未报告次要终点
研究者
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