NCT00639782已完成不适用
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 857
- 试验地点
- 56
- 主要终点
- Thromboembolisms
研究概览
简要总结
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
详细描述
The study is a multi-centre, randomized trial that will sequentially enroll up to 500 eligible patients in each group from up to 10 participating study centres internationally to test the hypothesis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient requires an isolated mitral or isolated aortic valve replacement. (Patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.)
- •The patient is a candidate for receipt of a mechanical heart valve.
- •The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
- •The patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient.
排除标准
- •The patient is not a candidate to receive a mechanical heart valve.
- •The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
- •The patient requires a tricuspid valve replacement.
- •The patient is enrolled in another investigative study or trial.
结局指标
主要结局
Thromboembolisms
时间窗: 5 years
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
次要结局
未报告次要终点
研究者
研究点 (56)
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