NCT01563848Unknown2 期
Cryoablation in Patients With Atrial Flutter
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percentage of AF burden
研究概览
简要总结
The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ECG documented paroxysmal or persistent AFL
- •No prior documented history of AF
- •Patient undergoing RFA of the CTI for AFL.
- •No indication (other than AFL) for continued anticoagulation with warfarin.
- •No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
- •Availability of an analog phone line.
排除标准
- •a history of atrial fibrillation
- •Previous AF ablation procedure
- •Congestive heart failure
- •Left Ventricle ejection fraction less than 35%
- •Unwillingness to participate
结局指标
主要结局
Percentage of AF burden
时间窗: 3 years
次要结局
- thromboembolic events(3 years)
- hospitalizations(3 years)
- procedural complications(3 years)
- drug adverse effects(3 years)
- number of crossovers(3 years)
- All-cause death(3 years)
研究者
研究点 (2)
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