NCT01695824已完成2 期
Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Systemic embolism
研究概览
简要总结
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- •Eligible for long term warfarin
- •CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])
排除标准
- •Contraindicated for warfarin
- •Contraindicated for aspirin or clopidogrel (Plavix)
- •CHF Class 4
- •Implanted mechanical valve
- •Atrial septal or Patent Foramen Ovale (PFO) device
- •Platelets < 100,000 or hemoglobin < 10
- •Left ventricular ejection fraction (LVEF) < 30%
研究组 & 干预措施
LAA occluder
Active Comparator
干预措施: LAA occluder (Device)
LAA occluder
Active Comparator
干预措施: RFA ablation (Procedure)
LAA occluder
Active Comparator
干预措施: Warfarin (Drug)
Warfarin
Active Comparator
干预措施: RFA ablation (Procedure)
Warfarin
Active Comparator
干预措施: Warfarin (Drug)
结局指标
主要结局
Systemic embolism
时间窗: 12 months
Cardiovascular death
时间窗: 12 months
All stroke
时间窗: 12 months
次要结局
- 30 day major adverse event (MAE)(30 days)
- Left atrial appendage (LAA) coverage(45 days)
- Technical success(45 days)
- Procedure success(45 days)
研究者
研究点 (1)
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