跳至主要内容
临床试验/NCT04399499
NCT04399499Unknown不适用

Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Mortality

研究概览

简要总结

Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).

It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • older than 18 years old

排除标准

  • multiorgan failure,
  • inadequate peripheral access because of vascular disease,
  • not suitable mitral valve anatomy.

结局指标

主要结局

Mortality

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agricola Eustachio

Professor

IRCCS San Raffaele

研究点 (1)

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