A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
研究概览
简要总结
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis.
This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
- •The patients agree to join the study and sign the ICF
排除标准
- •No specific exclusion criteria
结局指标
主要结局
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
时间窗: 7-15 years after heart valve replacement surgery (during 2001-2007)
This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography
次要结局
未报告次要终点