NCT04634708已完成不适用
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- EXCOR Active device performance
研究概览
简要总结
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
详细描述
The study has a prospective, multicenter, international, single arm, observational design.
Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system,
- •Age < 18 years,
- •Patient and legal guardian has consented via signature on the study informed consent form,
- •Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator.
排除标准
- •Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system,
- •Patient and/or legal representative has not given written consent to participate in the study (non-consent),
- •Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.
结局指标
主要结局
EXCOR Active device performance
时间窗: 52 days
次要结局
- Successful patient outcome rates(Whenever it happens or 52 days)
研究者
研究点 (1)
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