Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months
研究概览
简要总结
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR
详细描述
Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR.
Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index.
Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic aortic stenosis
- •Prior geriatric evaluation
- •Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months
- •Patient given his non-opposition to using his data
- •Patient affiliated to the French social security.
- •Exclusion criteria:
排除标准
- 未提供
结局指标
主要结局
Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months
时间窗: at 6 months
次要结局
- Survival rate at 6 months, 9 months, 12 months(at 6, 9 and 12 months)
- Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months(at 6 months)
- Score of Barthel(at 6, 9 and 12 months)
- Survival time after TAVI during the study(up to 30 months)