WATCHMAN FLX Pro European Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 20
- 主要终点
- Number of participants with a safety event treated with the WATCHMAN FLX Pro
研究概览
简要总结
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device. In a subregistry with approximately 300 patients, it is intended to use the VersaCross Connect™ LAAC Access Solution.
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
- •Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device.
- •Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU).
- •Subject or legal representative who are willing and capable of providing informed consent.
- •Subject is able and willing to return for required follow-up visits and examinations.
- •Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law.
排除标准
- •Subject has a documented life expectancy of less than 12 months.
- •Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- •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.
- •Subject has a known hypersensitivity or contraindications according to IFU.
- •Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
研究组 & 干预措施
WATCHMAN FLX Pro
This arm is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.
Approximately 300 patients undergo the LAAC procedure in conjunction with the use of the VersaCross Connect™ LAAC Access Solution.
干预措施: Left atrial appendage closure (Device)
结局指标
主要结局
Number of participants with a safety event treated with the WATCHMAN FLX Pro
时间窗: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
Proportion of subjects with one or more of the following events between the time of procedure 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 minor nonsurgical treatments of access site complications are excluded from this endpoint.
Number of participants with a safety event treated with the VersaCross Connect™ LAAC Access Solution
时间窗: Between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later
Proportion of subjects with one or more of the following events between the time of procedure and within 7 days following the procedure or by hospital discharge, whichever is later: For all enrolled subjects, who had an attempt to insert the VersaCross Connect™ LAAC Access Solution device, the composite rate of all-cause death, all stroke, systemic embolism, pericardial effusion resulting in interventions\*, and ISTH major bleeding. \*Pericardial effusion/tamponade requiring pericardiocentesis or surgery to treat
Number of participants with a successful VersaCross Connect™ LAAC Access Solution treatment
时间窗: Completion of transseptal puncture
VersaCross Connect™ LAAC Access Solution acute procedural success: Acute Procedural Success is defined as transseptal puncture success (VersaCross RF-wire crossing into left atrium).
次要结局
未报告次要终点