Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Reduced aortic valve leaflet motion
研究概览
简要总结
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
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
- •Implanted with a sutureless Perceval (Sorin Group) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
- •Provide written informed consent
排除标准
- •Contraindication for CT with intravenous contrast injection
结局指标
主要结局
Reduced aortic valve leaflet motion
时间窗: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
次要结局
未报告次要终点
研究者
Magnus Dalén
MD
Karolinska University Hospital