Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in aortic transvalvular gradient measured by transthoracic echocardiography
研究概览
简要总结
The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.
详细描述
The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.
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
- •aortic valve reconstruction using autologous Pericardium (OZAKI technique)
排除标准
- •missing informed consent
结局指标
主要结局
Change in aortic transvalvular gradient measured by transthoracic echocardiography
时间窗: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography
次要结局
- occurence of stroke(From Baseline (end of cardiac surgery) until 12 months after cardiac surgery)
- occurence of cardiac re-surgery(From Baseline (end of cardiac surgery) until 12 months after cardiac surgery)
- occurence of death(From Baseline (end of cardiac surgery) until 12 months after cardiac surgery)