Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Successful Implantation of WATCHMAN FLX Device
研究概览
简要总结
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.
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
- •The patients is eligible to undergo WATCHMAN device implant procedure.
- •The patient is eligible for short term anticoagulation therapy.
- •Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
- •Ability to give informed consent for the procedure.
- •The patient is able and willing to undergo the procedure under moderate sedation.
- •The patient is able and willing to return for required 45-day transesophageal echocardiogram (TEE).
排除标准
- •Patient has contraindication for short term anticoagulation.
- •The patient has history of a hypercoagulable state per medical record documentation.
- •Pregnancy or planning to get pregnant during the investigation.
结局指标
主要结局
Successful Implantation of WATCHMAN FLX Device
时间窗: 45 days post procedure
Number of participants with a successfully implanted WATCHMAN FLX device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak \<5 mm) as assessed by a core lab interpretation of the transesophageal echocardiogram (TEE) 45 days post-implant.
Major Complications
时间窗: up to 7 days post procedure
Number of participants who experience major complications defined as major bleeding (intracranial bleeding, or bleeding requiring blood transfusion), pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death).
次要结局
- Procedure Conversion to General Anesthesia(baseline)
- Iatrogenic Atrial Septal Defect(45 days post procedure)
研究者
Mohamad Adnan Alkhouli
Principal Investigator
Mayo Clinic