NCT06765226招募中不适用
Abiomed Impella Pump Return Registry - Observational Study
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
- 200
- 试验地点
- 7
- 主要终点
- Investigate deposits and biomaterial after use of pump
研究概览
简要总结
Analysis of cell and protein deposits on the Impella Heart Pump.
详细描述
The Impella heart pump supports patients in cardiogenic shock for various reasons and has passed safety and biocompatibility evaluations. The planned investigation aims to further analyze cell and protein adhesion on these pumps and the effects of their prolonged use, especially in scenarios like bridge-to-transplant, recognizing preclinical testing limitations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for > 4 days
排除标准
- •Age < 18 years
结局指标
主要结局
Investigate deposits and biomaterial after use of pump
时间窗: through study completion, at least 25 days
investigate Impella 5.5 pumps after use regarding deposits and biomaterial
次要结局
- Relation deposits and biomaterial to clinical events(through study completion, at least 25 days)
研究者
研究点 (7)
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