Abiomed Impella V-A ECMO AUTO Mode - Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Gather clinical event data
研究概览
简要总结
Abiomed Impella V-A ECMO AUTO Mode - Observational Study
详细描述
The overall objective of this study is to collect data during routine Impella usage in an ECpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated Impella mode to run in conjunction with a VA ECMO system for continued assessment and development of the underlying algorithms in different clinical settings.
The primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm for the Impella pump. This is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the AIC out of the operational console data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with ongoing or planned ECpella therapy
排除标准
- •Age < 18 years
- •Treatment with other than VA ECMO setup
- •Treatment with Impella CP® heart pump only
结局指标
主要结局
Gather clinical event data
时间窗: Until one of the devices is permanently weaned, on average 5 days
Collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm
Usability assessment
时间窗: Until study completion, an average of 1 year
Confirmation of usability and ease of use by collection of user data and operational console data
次要结局
未报告次要终点