HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 949
- 试验地点
- 90
- 主要终点
- Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
研究概览
简要总结
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is of legal age to participate in the study.
- •Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
- •Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.
- •Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
- •Subject is able and willing to return for required follow-up visits and examinations.
排除标准
- •Subject has a documented life expectancy of less than 6 months.
- •Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
- •Intracardiac thrombus is present.
- •An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
- •The LAA anatomy will not accommodate a Closure Device.
- •The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
- •Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
- •There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
- •Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
结局指标
主要结局
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
时间窗: 45 days
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
时间窗: 6 months
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
次要结局
未报告次要终点