NCT00619151终止不适用
A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Effective Orifice Area (EOA)
研究概览
简要总结
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.
排除标准
- •Patients < 18 years of age
- •Emergency surgery
- •Pre-existing valve prosthesis
- •Aortic root replacement
- •Active endocarditis
研究组 & 干预措施
1
Active Comparator
CarboMedics Supra-annular Top Hat Valve
干预措施: Top Hat (Device)
2
Active Comparator
St. Jude Medical Regent Valve
干预措施: Regent (Device)
结局指标
主要结局
Effective Orifice Area (EOA)
时间窗: 6 month evaluation
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
Aortic Mean Gradient
时间窗: 6 months
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.
次要结局
未报告次要终点
研究者
研究点 (2)
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