The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Progression of atrial fibrillation
研究概览
简要总结
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
详细描述
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. 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 80 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) symptomatic paroxysmal atrial fibrillation episodes 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
CABG+pulmonary vein isolation
CABG+pulmonary vein isolation procedure
干预措施: CABG+Pulmonary vein isolation procedure (Procedure)
Isolated CABG
Isolated CABG procedure
干预措施: Isolated CABG (Procedure)
结局指标
主要结局
Progression of atrial fibrillation
时间窗: up to 36 months
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF. 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)
- Hospitalization due to atrial fibrillation after surgery(Within three years after surgery)
研究者
Alexander Romanov
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation