NCT02400489已完成不适用
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
Edwards Lifesciences3 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2014年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 3
- 主要终点
- Twice echocardiography to evaluate the performance of heart valve
研究概览
简要总结
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.
To track the patients'situations during one year after surgery and to collect the relevant clinical data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
- •Patients sign the Inform Consent Form (ICF) and agree to join the study
排除标准
- •Don't have any specific exclusion criteria.
结局指标
主要结局
Twice echocardiography to evaluate the performance of heart valve
时间窗: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
subjects need to do the echocardiography in two follow up visits
The recovery status of patients after surgery
时间窗: The subjects will be followed for the duration of one year after surgery
次要结局
未报告次要终点
研究者
研究点 (3)
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