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临床试验/NCT02711540
NCT02711540Unknown不适用

Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke Rates in the United Kingdom

Royal Sussex County Hospital0 个研究点目标入组 4,000 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,000
主要终点
Stroke

研究概览

简要总结

Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

详细描述

Retrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Factors to be examined include (but not limited to):

need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for post-dilatation need for rapid ventricular burst pacing

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

  • Had TAVI procedure in UK

排除标准

  • 未提供

结局指标

主要结局

Stroke

时间窗: 30 days

Stroke, defined as new neurological deficit with corresponding change on CT scan of brain, is a self reported event following TAVI. All centres performing TAVI in the United Kingdom are required to report this to the National Institute for Cardiovascular Outcomes Research (NICOR) registry which is being analysed in this study

次要结局

未报告次要终点

研究者

发起方
Royal Sussex County Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Hildick-Smith

Consultant Cardiologist

Royal Sussex County Hospital

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