Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Structural valve deterioration
研究概览
简要总结
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.
The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.
详细描述
In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements, the study aims to retrospectively collect safety outcomes and performance data in patients with aortic valve disease implanted with Perceval S since 2022. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.
Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration, cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism, major bleeding, re-operation will be studied to describe the safety profile of the valve.
Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient, effective orifice area, effective orifice area indexed, incidence and degree of PVL and central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects will be collected in four clinical sites in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who has been implanted with Perceval S sutureless aortic heart valve
- •Subject (legal representative or family member) who has signed the approved informed consent or would provide verbal informed consent/ signed and dated informed consent, and available medical information
排除标准
- •Subject (legal representative or family member) who do not provide consent to the data collection
结局指标
主要结局
Structural valve deterioration
时间窗: up to 1 year
The number and percentage of subjects with Structural valve deterioration
Stroke
时间窗: up to 1 year
The number and percentage of subjects with stroke
Transient Ischemic Attack (TIA)
时间窗: up to 1 year
The number and percentage of subjects with Transient Ischemic Attack (TIA)
Re-operation
时间窗: up to 1 year
The number and percentage of subjects with re-operation
Major bleeding
时间窗: up to 1 year
The number and percentage of subjects with major bleeding
Mortality
时间窗: up to 1 year
The number and percentage of subjects died
Cerebral thromboembolism
时间窗: up to 1 year
The number and percentage of subjects with Cerebral thromboembolism
Non-cerebral thromboembolism
时间窗: up to 1 year
The number and percentage of subjects with non-cerebral thromboembolism
次要结局
- Effective Orifice Area (EOA)(at discharge or 7 days post-procedure (whichever comes first))
- Aortic Mean Pressure Gradient (MPG)(at discharge or 7 days post-procedure (whichever comes first))
- Effective Orifice Area Index (EOAi)(at discharge or 7 days post-procedure (whichever comes first))
- Aortic Peak Pressure Gradient (PPG)(at discharge or 7 days post-procedure (whichever comes first))
- Aortic Regurgitation(at discharge or 7 days post-procedure (whichever comes first),)