NCT02549963Unknown4 期
A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation
Shulin Wu9 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Combined endpoint
研究概览
简要总结
This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 LAAO and long-term rivaroxaban therapy
- •Calculated CHA2DS2-VASc score of 2 or greater.
排除标准
- •Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
- •Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
- •History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
- •History of valvular heart disease.
- •Implanted mechanical valve prosthesis.
- •New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%.
- •Patient has left atrial/left atrial appendage thrombus screened by echocardiography
- •Platelet<100*109/L or hemoglobin<100g/L
- •Expected lifespan less than 1 years
研究组 & 干预措施
WATCHMAN LAA Occlusion Device
Experimental
Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.
干预措施: WATCHMAN Left Atrial Appendage Occlusion Device (Device)
Rivaroxaban
Active Comparator
Subjects assigned to receive the Rivaroxaban therapy.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Combined endpoint
时间窗: 2 year
All Stroke or Systemic embolism or Cardiovascular death
次要结局
- Major bleeding event(2 year)
- Technical and procedure related event(45 days)
- Cognitive function change(2 year)
- All bleeding event(2 year)
研究者
Shulin Wu
Director of Guangdong Cardiovascular Institute
Guangdong Provincial People's Hospital
研究点 (9)
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