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临床试验/NCT05464472
NCT05464472Unknown不适用

Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Helios University Hospital Wuppertal1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
neurocognitive performance for depression

研究概览

简要总结

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

详细描述

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis >75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • planned TAVI implantation
  • Intelligence quotient > 80
  • Sufficient knowledge of German
  • Normal or corrected vision and hearing

排除标准

  • Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
  • Oncological disease with a life expectancy < 12 months
  • pregnancy

结局指标

主要结局

neurocognitive performance for depression

时间窗: 6 month post TAVI

Becks Depression Inventory (BDI)

neurocognitive performance for health status

时间窗: 6 month post TAVI

Questionnaire on health status (SF 36)

次要结局

未报告次要终点

研究者

发起方
Helios University Hospital Wuppertal
申办方类型
Other
责任方
Sponsor

研究点 (1)

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