Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Freedom from AF recurrence between 91 and 365 days
研究概览
简要总结
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
详细描述
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
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
- •Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
- •Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.
- •Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
- •Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
- •Able and willing to comply with pre-, post-, and follow-up requirements.
排除标准
- •Left atrial thrombus by pre-procedural imaging.
- •Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%
- •Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
- •Stroke or any thrombo-embolic events within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •History of cardiac surgery.
- •Uncontrolled maligment tumor.
- •Patients in dialysis or creatinine > 221 μmol/L.
- •Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L
- •Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.
- •Life expectancy less than 1 year.
- •Women who are pregnant or who plan to become pregnant during the study.
- •Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
研究组 & 干预措施
PVI
Pulmonary vein isolation (PVI)
干预措施: PVI (Procedure)
PVI+6L
PVI plus 6 additional lines at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
干预措施: CPVI+6L (Procedure)
结局指标
主要结局
Freedom from AF recurrence between 91 and 365 days
时间窗: 91 to 365 days
AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.
次要结局
- Early onset complications(Within 30 days)
- AF burden(12 months)
- Procedural time(Within procedure)
- Fluoroscopy time(Within procedure)
- Ablation time(Within procedure)
- Late onset complications(within 12 months)
研究者
Yi-Gang Li
Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine