Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- measurement of postoperative trans-valvular mean gradient by echocardiography
研究概览
简要总结
This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
详细描述
According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.
Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.
Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery
排除标准
- •no endocarditis
结局指标
主要结局
measurement of postoperative trans-valvular mean gradient by echocardiography
时间窗: after 6 months
次要结局
- Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces(at six months.)
- Comparison between the aortic annulus measurement and the implanted bioprosthesis size(at six months)
- Surgical outcome at hospital(at 6 months.)
- Postoperative trans-valvular mean gradient by echocardiography(at six months.)
- Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size(at six months)