NCT01514162已完成不适用
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 12
- 主要终点
- Late Adverse Event Incidence
研究概览
简要总结
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
详细描述
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
- •Subject met eligibility criteria of IDE study
- •Subject agrees to complete study follow-up visits
- •Subject provides written informed consent
排除标准
- •Subject currently participating in another device or drug study
- •Subject unable or unwilling to return for study follow-up visits
研究组 & 干预措施
Trifecta Valve Group
Experimental
Subjects implanted with a Trifecta valve.
干预措施: Trifecta valve (Device)
结局指标
主要结局
Late Adverse Event Incidence
时间窗: 5 years
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
次要结局
- Characterize Patient NYHA Functional Classification Status(5 years)
- Report the Hemodynamic Performance of the Valve(5 years)
研究者
研究点 (12)
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