Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 5
- 主要终点
- Number of deceased participants at 1 month after cardiogenic shock
研究概览
简要总结
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
详细描述
This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative).
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.
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
- •Age > 18 years
- •Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
- •Signed informed consent by patient or relative or waived consent by EC
排除标准
- 未提供
结局指标
主要结局
Number of deceased participants at 1 month after cardiogenic shock
时间窗: 30 days
All-cause mortality at 30 days
次要结局
- Support time under MCS(6 months)
- Statistical and medical analysis of vascular complications (VARC) reported by participants(6 months)
- Statistical and medical analysis of vascular surgery needed by participants(6 months)
- Analysis of New York Heart Association (NYHA) Classification for participants(6 months)
- Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants(6 months)
- Implantation time of MCS-device(6 months)
- Modified rankin scale(6 months)
- Statistical and medical analysis of bleeding complications (minor, major) reported by participants(6 months)
- Number of deceased participants at 6 month after cardiogenic shock(6 months)