Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Restoration of sinus rhythm
研究概览
简要总结
It is planned to evaluate the efficacy and safety of the class III antiarrhythmic drug refralon as a drug for pharmacological cardioversion in patients with recurrent atrial fibrillation (AF) and atrial flutter (AFL) after catheter ablation.
详细描述
Atrial fibrillation and atrial flutter are the most common arrhythmias among the adult population of the world, their share in the population is from 2 to 4% and continues to grow.
Modern highly effective methods of minimally invasive surgical treatment of these types of arrhythmia are currently catheter radiofrequency ablation and balloon cryoablation of the pulmonary veins. According to the CABANA study, catheter interventions reduce the risk of recurrent AF/AFL by 47%, significantly improving arrhythmia tolerance and improving the quality of life of patients.
An important problem is the recurrence of arrhythmia after the intervention, the frequency of recurrence of AF/AFL in the first 3 months after ablation (the so-called early recurrence) is 50-60%. In many patients, these recurrence are accompanied by severe clinical manifestations, which require pharmacological or electrical cardioversion.
In order to restore sinus rhythm, electrical cardioversion is most often used, the effectiveness of which is 90-92%.
An alternative to electrical cardioversion is pharmacological cardioversion, however, antiarrhythmic drugs used in wide clinical practice can restore sinus rhytm (SR) only in patients with recent AF paroxysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal or persistent forms of AF/AFL and early (less than 90 days) or late (more than 90 days) arrhythmia recurrence after catheter radiofrequency ablation or balloon cryoablation of pulmonary veins.
- •Indications for SR recovery.
- •Consent of the patient.
排除标准
- •Arrhythmogenic effect of antiarrhythmic drugs III class in history;
- •Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;
- •Chronic heart failure (functional class IV);
- •Acute coronary syndrome;
- •Bronchial asthma of an uncontrolled course and / or severe respiratory failure.
- •The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal
- •Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);
- •Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);
- •Bradysystolic atrial fibrillation (heart rate <50 beats/min);
- •Duration of the QT interval >440 ms;
- •Hemodynamic instability requiring emergency cardioversion;
- •Contraindications to anticoagulant therapy;
- •Thyrotoxicosis or decompensated hypothyroidism;
- •Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
- •Pregnancy and breastfeeding period.
研究组 & 干预措施
Refralone group
Patients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon
干预措施: Pharmacological cardioversion with Refralon (Drug)
结局指标
主要结局
Restoration of sinus rhythm
时间窗: 24 hour
Restoration of SR within 24 hours from the moment of administration of the first dose of refraloRestoration of SR within 24 hours from the moment of administration of the first dose of refralon
Increased QT interval (more than 500 ms)
时间窗: 24 hours
The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms.
Preservation of SR
时间窗: 24 hours
Preservation of SR 24 hours after the first dose of refralon.
Ventricular arrhythmogenic effect
时间窗: 24 hours
Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug
次要结局
- Pauses more than 5 seconds(24 hours)
- Restoration of sinus rhythm within 6 hours(6 hours)
- Number of patients recovering SR after minimal doses(24 hours)
- Reccurence after SR recovery(24 hours)
- Bradyarrhythmias (pauses and bradycardia)(24 hours)