Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
研究概览
简要总结
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.
There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.
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
- •Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
- •written and verbal consent
排除标准
- •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
- •Left atrial diameter less than 55mm assessed by transthoracic echocardiography
- •Renal insufficiency requiring dialysis
- •Heart valve disease requiring invasive treatment
- •Heart anomaly requiring regular controls and/or invasive treatment
研究组 & 干预措施
CABG, AVR or CABG+AVR and PVI
Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG
干预措施: CABG, AVR or CABG+AVR and PVI (Procedure)
CABG, AVR or CABG+AVR
Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation
干预措施: CABG, AVR or CABG+AVR (Procedure)
结局指标
主要结局
Freedom of symptomatic and asymptomatic atrial fibrillation after surgery
时间窗: Within one year after operative treatment
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Freedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring
Atrial fibrillation burden
时间窗: Within one year after operative treatment
Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring
次要结局
- Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation(Within one year after operative treatment)
- Anti-arrhythmic treatment after surgery(Within one year after treatment)
- Adverse events after surgery in both arms(Within one year after operative treatment)
- Hospitalization due to atrial fibrillation after surgery(Within one year after operative treatment)
- Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding(Within one year after operative treatment)
- Cardioversion for the treatment of atrial fibrillation after surgery(Within one year after operative treatment)