Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Freedom from atrial fibrillation
研究概览
简要总结
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
详细描述
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG
- •At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months
- •The patient's consent to participate in the study
排除标准
- •Intolerance of antiarrhythmic drugs
- •Heart valve disease requiring invasive treatment
- •Left atria more than 6.5 cm
- •Prior cardiac surgery
- •Active pacemaker treatment
- •Active anti-arrhythmic treatment (AAD) class I and III
- •Contraindication to oral anticoagulant/heparin treatment
- •Ejection fraction less than 30 % (EF < 30 %) assessed by transthoracic echocardiography
研究组 & 干预措施
Biatrial radiofrequency ablation and CABG
Biatrial radiofrequency ablation during CABG
干预措施: Biatrial radiofrequency ablation and CABG (Procedure)
Left atrial radiofrequency ablation and CABG
Left atrial radiofrequency ablation during CABG
干预措施: Left atrial radiofrequency ablation and CABG (Procedure)
结局指标
主要结局
Freedom from atrial fibrillation
时间窗: up to 36 months
Freedom from AF. All cases of AF after surgical intervention. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF\>0.5% were classified as non-responders.
次要结局
- Cardiovascular events(Within three years after surgery)
研究者
Alexander Romanov
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation