Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
详细描述
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over
- •Scheduled to undergo TAVI
- •Provide informed consent
- •Able to understand French
排除标准
- •subjects under legal guardianship or other legal protection
- •subjects with documented severe dementia
- •subjects with anticipated poor compliance
- •subjects unable to understand French sufficiently well to perform the MoCA test
- •pregnant women
- •subjects within the exclusion period of another study
结局指标
主要结局
All-cause death
时间窗: through 30 days after the TAVI procedure
Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death
Stroke
时间窗: through 30 days after the TAVI procedure
Safety outcome at 30 days as assessed by the VARC2 criteria: stroke
life-threatening bleed
时间窗: through 30 days after the TAVI procedure
Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed
Combined VARC2 safety outcome
时间窗: through 30 days after the TAVI procedure
Safety criteria (within 30 days of the procedure) include all-cause death; stroke; life-threatening bleed; renal insufficiency; coronary artery obstruction requiring intervention; major vascular complication; valve dysfunction. Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-rela
Combined VARC2 efficacy outcome
时间窗: through 30 days after the TAVI procedure
Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-related symptoms or worsening heart failure; NYHA Class III or IV; valve-related dysfunction.
次要结局
- Time required for MoCA(At the time of MoCA completion)
- Relationship between MoCA score and each component of the VARC2(At 3 months after TAVI procedure)
- Biological parameters pre-procedure(pre-procedure)