NCT00475267已完成不适用
An Observational, Prospective Evaluation of the Trifecta Valve
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 10
- 主要终点
- Characterize the hemodynamic performance of the valve.
研究概览
简要总结
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
详细描述
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
- •Legal age.
- •Signed informed consent prior to surgery.
- •Willing to complete all follow-up requirements.
排除标准
- •Pregnant or nursing women.
- •Have already had a valve replaced other than the aortic valve.
- •Needs another valve replaced.
- •Cannot return for required follow-up visits.
- •Have active endocarditis.
- •Acute preoperative neurological event (such as a stroke).
- •Renal dialysis.
- •History of substance abuse within one year, or a prison inmate.
- •Participating in another study.
- •Life expectancy less than two years.
结局指标
主要结局
Characterize the hemodynamic performance of the valve.
时间窗: At required follow-up intervals
Characterize patient NYHA functional classification status.
时间窗: At required follow-up intervals
Establish adverse event rates.
时间窗: Ongoing
次要结局
未报告次要终点
研究者
研究点 (10)
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