Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Comprehensive geriatric assessment
研究概览
简要总结
Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.
It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned
详细描述
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
- •Compliance with the indications of the instructions for use
- •Age of at least 80 years
- •Written informed consent
排除标准
- •Presence of contraindications as to the Instructions for Use
- •No possibility for a follow-up
结局指标
主要结局
Comprehensive geriatric assessment
时间窗: Baseline and 3 months
Demonstrate CGA changes within 3 months after TAVI The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.
次要结局
- Score development(after 3 months)
- predictive Value of CGA Tavi(baseline)