NCT02654470已完成不适用
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- procedural complications
研究概览
简要总结
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
详细描述
WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Subjects who are eligible for a WATCHMAN FLX device according to current international and local guidelines and currently approved indications;
- •Subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
- •Subjects 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
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the Subject 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
- •The subject is unable or not willing to complete follow-up visits and examinations for the duration of the study
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
- •Documented life expectancy of less than 12 months.
结局指标
主要结局
procedural complications
时间窗: 7-days post implant
procedural success
时间窗: 7 days post-implant
incidence of stroke, leak, thrombus and death
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (17)
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