NCT01264484终止不适用
ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
Medtronic Bakken Research Center2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2010年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Long-term safety and durability of the valve
研究概览
简要总结
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
详细描述
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve in patients who were already implanted with this device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the ADVANTAGE Prosthetic Heart Valve Study in Herz- und Diabeteszentrum (Bad Oeynhausen) or Deutsches Herzzentrum (Munich)
- •Signed and dated patient data release form
- •Available for follow-up
排除标准
- •High probability of non-adherence to physician's follow-up requirements
结局指标
主要结局
Long-term safety and durability of the valve
时间窗: 5 year follw-up
The long-term safety of the valve will be assessed by the rate of valve related complications. The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve
次要结局
未报告次要终点
研究者
研究点 (2)
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