NCT00705913终止不适用
A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 368
- 试验地点
- 24
- 主要终点
- Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
研究概览
简要总结
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
详细描述
Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.
排除标准
- •Less than 18 years of age
- •Emergency Surgery
- •Pre-existing valve prothesis in the aortic position
- •Aortic root replacements or enlargements
- •Active endocarditis
结局指标
主要结局
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
时间窗: 6 months
次要结局
- Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.(6 months)
研究者
研究点 (24)
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