Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants who are free from atrial fibrillation (AF)
研究概览
简要总结
This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.
详细描述
Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed.
Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent symptomatic AF with failure of at least 1 anti-arrhythmic drug
- •Prior pulmonary vein isolation (PVI)
- •CHA2DS2VASC > 0
- •Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban
排除标准
- •Inability to follow-up as per protocol
- •Prior valvular surgery or valve replacement
- •Reversible cause for atrial fibrillation
- •Currently on dialysis or renal replacement therapy
- •Need for concomitant cardiac surgery
- •History of MI or stroke ≤2 months prior to ablation
- •Intolerance to oral anticoagulants
- •Thrombus in the Left atrial appendage
研究组 & 干预措施
Mini-maze surgical procedure
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
干预措施: Mini-maze surgical procedure (Procedure)
Catheter Ablation
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Number of participants who are free from atrial fibrillation (AF)
时间窗: 12 months after the procedure
次要结局
- Number of participants who are at risk of stroke(12 months after the procedure)
- Number of participants who experienced a procedural complication(2 weeks after the procedure)
- AF burden as assessed by the CCA-SAF(12 months after the procedure)
- Number of participants who were hospitalized for cardiovascular events(12 months after the procedure)