Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- accuracy of aortic valve sizing by preoperative CT scan of the heart
研究概览
简要总结
This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.
详细描述
Patients with severe aortic stenosis undergo aortic valve replacement (AVR). One approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. Until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. Due to the implantation mechanism, the valve has to be collapsed after determination of the size. This is consuming time and can seriously delay the procedure.
This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implantation of a Sorin Perceval ® sutureless valve
- •availability of preoperative CT scan
排除标准
- •denial of consent
- •missing preoperative CT scan
- •bad quality of preoperative CT scan
结局指标
主要结局
accuracy of aortic valve sizing by preoperative CT scan of the heart
时间窗: during surgery procedure
accuracy of aortic valve sizing by preoperative CT scan of the heart in comparison with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer)
次要结局
未报告次要终点