The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- cognition
研究概览
简要总结
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.
详细描述
The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.
In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
- •Women and men between the ages of 19 and 90
- •Clinical indication for TAVI intervention
- •No previous psychiatric illness before TAVI
- •No other serious disease affecting the immune system
排除标准
- •Non-compliance with the inclusion criteria
- •Persons unable to give consent (e.g. dementia, delirium etc.)
- •Magnetic resonance imaging (MR) contraindications
- •ophthalmological inability to read
结局指标
主要结局
cognition
时间窗: 12 months
Montreal-Cognitive-Assessment, cognitive test battery
次要结局
- health-related quality of life(12 months)
研究者
Andreas Baranyi
Prof.
Medical University of Graz