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临床试验/NCT03583970
NCT03583970Unknown不适用

Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年7月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
6-month hospital discharge after LVAD implantation

研究概览

简要总结

Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.

LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.

In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
  • Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time

排除标准

  • ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
  • Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation

结局指标

主要结局

6-month hospital discharge after LVAD implantation

时间窗: 6 month after LVAD implantation

6-month hospital discharge after LVAD implantation

次要结局

  • Mortality rate(up to six month after LVAD implantation)
  • ICU discharge(up to six month after LVAD implantation)
  • Quality of life(up to six month after LVAD implantation)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caroline FRITZ

MD

Central Hospital, Nancy, France

研究点 (1)

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