Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Silent cerebral embolism
研究概览
简要总结
The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.
详细描述
Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.
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
- •aortic valve replacement
排除标准
- •contraindication to undergo MRI
结局指标
主要结局
Silent cerebral embolism
时间窗: 48 hours
次要结局
- Apparent cerebral embolism(48 hours)
研究者
Claas P. Naehle
Assistant Professor of Radiology
University Hospital, Bonn