Comparative Analysis of Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Cerebral events
研究概览
简要总结
Atrial fibrillation (AF) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. Ischemic stroke in patients with AF is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. Accordingly, the risk of death in patients with AF-related stroke is 2 times higher, and treatment costs increase 1.5 times.
The main interventional method of treating AF, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (LA).
The aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term AF.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old;
- •Atrial fibrillation resistant to antiarrhythmic therapy;
- •Persistent and long-persisting form of atrial fibrillation;
- •The patient's consent to participate in the study.
排除标准
- •Age under 18 and over 80 years old;
- •The presence of another cardiac pathology requiring surgical treatment;
- •Congenital heart defects;
- •Previous "open" cardiac surgery;
- •Bone marrow diseases;
- •Pathology of the blood coagulation system;
- •The left ventricular ejection fraction is less than 40%;
- •Moderate to severe renal insufficiency (creatinine clearance <50 ml/min);
- •Drug-resistant hypertension (despite hypotensive therapy);
- •Organically altered mitral valve;
- •There are reasons to assume that the patient will not show up for subsequent visits (control points of the study) for various reasons;
- •The patient's participation in another clinical trial.
研究组 & 干预措施
Cryoablation
Cryoablation of the mouths of the pulmonary veins and the posterior wall of the left atrium.
干预措施: Cryoablation (Procedure)
Radiofrequency ablation
Radiofrequency ablation of pulmonary veins according to the "box isolation" type using a non-fluoroscopic navigation system.
干预措施: Radiofrequency ablation (Procedure)
结局指标
主要结局
Cerebral events
时间窗: From the date of ablation until the date of the event, assessed up to 24 months.
The number of patients who had a stroke or acute cerebrovascular accident or a transient ischemic attack within 24 months after ablation.
次要结局
- Recurrence of AF(From the date of ablation until the date of recurrent atrial fibrillation, assessed up to 24 months.)
- Hospital mortality(From the date of ablation until the date of death, assessed up to 5 days.)
- Long-term mortality(From the date of ablation until the date of death, assessed up to 24 months.)
- Non-lethal events(From the date of ablation to the date of any of the listed events, assessed up to 5 days.)