Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
研究概览
简要总结
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
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
- •Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- •Eligible for long-term Warfarin therapy;
- •Eligible to come off Warfarin therapy if the LAA is sealed
- •Calculated CHADS2 score of 1 or greater
排除标准
- •New York Heart Association Class IV Congestive Heart Failure
- •Recent MI (within 3 months)
- •ASD and/or atrial septal repair or closure device
- •Resting heart rate >110 bpm
- •Has an implanted mechanical valve prosthesis
- •Left atrial appendage is obliterated
- •Has undergone heart transplantation
- •Has symptomatic carotid disease
- •Contraindicated for aspirin
- •LVEF < 30%
- •Cardiac Tumor
结局指标
主要结局
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
时间窗: 12-Months
The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
Device Success
时间窗: Implant through 45-Days
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
次要结局
未报告次要终点