Observe the Safety and Effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Stroke in Hong Kong Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in Hong Kong area.
详细描述
This study is a prospective, non-randomized, multi-center observational study. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.The primary safety endpoint is the occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Secondary effectiveness endpoint is the occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;
- •Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
- •Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
排除标准
- •Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- •The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: First Follow-up (30 ~ 100 days);
The occurrence of non-effective LAA closure defined as any peri-device flow \> 5mm demonstrated by TEE/CT/MRI at First Follow-up.
Primary Safety Endpoint
时间窗: First Follow-up (30-100 days)
The occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint.
次要结局
- Secondary Endpoint(12-Month Follow-up (365 ± 30 days))