China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
研究概览
简要总结
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.
详细描述
In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:
- •not suitable for long-term anti-coagulation therapy;
- •stroke or embolism events in spite of warfarin treatment with intended INR
排除标准
- •Patient with any one of the following items will be excluded from the study:
- •clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life < 5 years
- •2 Echocardiography exclusion criteria (any of the items) a LVEF<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter >32mm or < 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area <1.5cm2)
- •3 subject is not able to or will not complete the follow ups as planned
结局指标
主要结局
composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
时间窗: 2 years
all-cause death, ischemic stroke, systemic embolism, or device or procedure related events
时间窗: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later
events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
次要结局
- All Major Complications.(up to 5 years)
- Implantation success rate.(procedure)
- Ischemic stroke or systemic embolism(excluding the first 7 days post enrollment.)
- All-cause death.(up to 5 years)
研究者
Shu Zhang
Director of Department of Arrhythmia
Fu Wai Hospital, Beijing, China