NCT01164319已完成3 期
Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
研究概览
简要总结
The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •highly symptomatic patients refractory to at least two antiarrhythmic drugs
- •patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.
排除标准
- •congestive heart failure
- •ejection fraction <35%
- •left atrial diameter >60 mm
- •previous ablation procedure
结局指标
主要结局
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
时间窗: 12 months
次要结局
- Freedom from AF in each group and the comparison of any group to each other(12 months)
研究者
研究点 (2)
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