ChiCTR-ONC-13003015招募中4 期
Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
SK Yee Funding, CUHK1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年2月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy endpoints: stroke, cardiovascular death, systemic embolic events at 6 months, 12 months
研究概览
简要总结
To assess the effect and safety of Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Adults above the age of 18;
- •Non-valvular AF, at high risk of stroke and who have experienced serious bleeding events or repeated nuisance bleed events whilst on warfarin or NOACs;
- •Non-valvular AF, at high risk of stroke and who are intolerant of, has significant side effect, or decline to take warfarin or NOACs;
- •Non-valvular AF, at high risk of stroke and who are poorly compliant with warfarin (Time in therapeutic range <60%) or NOACs;
- •Non-valvular AF, at high risk of stroke and who are at high risk of bleeding as evidenced by a high HAS-BLED score.
排除标准
- •Inability to take Aspirin and Clopidogrel;
- •Inability to give informed consent;
- •Patients unlikely to benefit from the therapy due to a short life expectancy;
- •Moderate-to-severe or worse mitral or aortic valvular regurgitation or stenosis;
- •Suspected or known intracardiac thrombus;
- •Symptomatic carotid disease.
研究组 & 干预措施
Two groups
Left Atrial Appendage (LAA) occlude: Watchman or ACP device; Duration of intervention: life long vs Nil
结局指标
主要结局
Efficacy endpoints: stroke, cardiovascular death, systemic embolic events at 6 months, 12 months
Safety endpoints: procedure-related ischaemic and hemorrhagic stroke, pericardial effusion, death
次要结局
- Adverse events at 12 months and 24 months
研究者
研究点 (1)
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