Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
研究概览
简要总结
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
详细描述
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
- •Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
- •Consent to surgical ablation of AF
排除标准
- •Paroxysmal AF
- •Degenerative or ischemic mitral valve disease
- •Evidence of active infection
- •Previous catheter ablation or surgical ablation for AF
- •Surgical management of hypertrophic obstructive cardiomyopathy
- •Absolute contraindications for anticoagulation therapy
- •Left atrial thrombosis (not including left atrial appendage thrombosis alone)
- •Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)<30% anticipated value)
- •Uncontrolled hypo- or hyperthyroidism
- •Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study
- •Left atrial diameter>70mm
- •Right ventricular dysfunction (TAPSE<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) >60mmHg
- •Coronary artery bypass grafting is required for participants with coronary heart disease
- •Previous cardiac surgery
- •Refuse to participate in this study
结局指标
主要结局
Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs
时间窗: At 12-month after intervention
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs.
次要结局
- Survival rate without permanent pacemaker implantation (Key secondary outcome)(At 12-month after intervention)
- Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs(At 12-month after intervention)
- Burden of atrial fibrillation(At 12-month after intervention)
- Major adverse events(At 12-month after intervention)
- Cardiac function(At 12-month after intervention)