Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Valve-related bleeding
研究概览
简要总结
The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.
The study is designed as a post-market, retrospective, single arm and multicentric data collection
详细描述
This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.
Valve-related SAEs such as prosthetic valve dysfunction, death, valve-related bleeding events, valve thrombosis and thromboembolic events, endocarditis and reintervention will be studied to describe the safety profile of the valve. Data of approximately 400 subjects will be collected in two clinical sites in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who has been treated with the Carbomedics OptiForm Mitral Heart Valve.
- •Subject (or representative or family member) who can understand the objective of the study and is willing to provide verbal informed consent and the available medical information.
排除标准
- •Subject (or legal representative or family member) who do not provide their verbal consent to the data collection, or who are unable to provide follow-up information
结局指标
主要结局
Valve-related bleeding
时间窗: up to 7-8 year
The number and percentage of subjects with Valve-related bleeding
Mortality
时间窗: up to 7-8 year
The number and percentage of subjects died
Thromboembolism
时间窗: up to 7-8 year
The number and percentage of subjects with Thromboembolic events
Endocarditis
时间窗: up to 7-8 year
The number and percentage of subjects with Endocarditis
Valve-Related Reintervention
时间窗: up to 7-8 year
The number and percentage of subjects underwent Valve-related reintervention
Prosthetic Valve Dysfunction
时间窗: up to 7-8 year
The number and percentage of subjects with Prosthetic valve Dysfuntion
Valve thrombosis
时间窗: up to 7-8 year
The number and percentage of subjects with Valve Thrombosis
次要结局
未报告次要终点