Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 3
- 主要终点
- the incidence rates of atrial tachyarrhythmias
研究概览
简要总结
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
详细描述
The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.
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
- None
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
- •Patients aged between 18-80 years
- •Patients with persistent (≥7 days) AF documented on 12-lead ECG or Holter monitoring.
- •AF refractory/intolerant to class I or III antiarrhythmic drugs
- •Able and willing to provide written informed consent to CB or RF ablation and participation in this investigation
排除标准
- •Age <18 years old or >80 years old
- •Paroxysmal AF lasting <7 days
- •Mitral stenosis or mechanical prosthetic valve
- •Patients with left atrial size ≥ 50 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view)
- •Anatomy of pulmonary vein not suitable for standard CB or extended CB, including common ostium or ostium size > 26mm
- •Pregnant woman of childbearing age with a positive pregnancy test before treatment
- •Presence of atrial septal defect or patent foramen ovale closure device
- •Presence of intracardiac thrombus
- •Contraindications to the systemic anticoagulation
- •NYHA functional class IV heart failure
- •Prior catheter or surgical ablation of AF
- •Acute coronary syndrome within 3 months
- •Planned open heart surgery within 3 months
- •Prior open-heart surgery within 3 months
- •End stage renal disease or chronic kidney disease (estimated glomerular filtration rate [MDRD method] < 30mL/min/1.73m²)
- •Life expectancy less than 1 year.
结局指标
主要结局
the incidence rates of atrial tachyarrhythmias
时间窗: 3-month blanking period post-procedure
Incidence of atrial tachyarrhythmias (including atrial fibrillation, flutter, or tachycardia) lasting \>30 seconds after discontinuation of antiarrhythmic therapy, assessed following a 3-month blanking period
次要结局
- Incidence of peri-procedural complications(Periprocedural)
- Atrial arrhythmia recurrence during blanking period(during blanking period (3 months))
- Atrial tachycardia or flutter recurrence(1 year)
- Atrial fibrillation recurrence(1 year)
- Rate of first-pass isolation or first-freeze isolation(during procedure)
- Procedure duration (minutes)(during procedure)
- Ablation time (minutes)(during procedure)
- Fluoroscopy time (minutes)(during procedure)
- LA dwelling time(during procedure)
- Ablation time (seconds)(during procedure)
- Quality of life changes at 12 months compared to baseline(1 year)
- Number of repeat procedures(1 year)
- AF burden by 2-week patch monitoring(1 year)
- LA pressure, mmHg (max/min/mean)(during procedure)
研究者
Gi-Byoung Nam
Professor
Asan Medical Center