NCT01703247已完成2 期
Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
研究概览
简要总结
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years with the use of an implanted monitoring device (IMD).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent and longstanding persistent AF
排除标准
- •congestive heart failure
- •LV ejection fraction < 35%
- •left atrial diameter > 60 mm
结局指标
主要结局
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
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