Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring
研究概览
简要总结
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label
详细描述
The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The indications for catheter ablation of atrial fibrillation
- •Signed informed consent to participate in the Register
- •Patients undergoing cryoballoon ablation
排除标准
- •Left atrial thrombosis
结局指标
主要结局
Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring
时间窗: 1 Year
ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening)
次要结局
- Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)(1 Year)
- Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)(Above parameters will be assessed only during the procedure of cryoablation)
- Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)(1 Year)
- Number of participants with antiarrhythmic drug treatment at 12 months(1 Year)