Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
- 试验地点
- 14
- 主要终点
- Arrhythmia Recurrence
研究概览
简要总结
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.
The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.
After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.
After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) < 0.5mV.
Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).
The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting > 30 seconds between day 91 and 365 after the index 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.
- •Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
- •Age 18-85 years.
- •Left atrial size < 55mm.
- •Left ventricular ejection fraction ≥ 45%.
- •Patient is able to provide informed consent and is willing to comply with the study protocol.
排除标准
- •Contraindications for repeat ablation
- •Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
- •Minimal diameter of LAA neck ≥25mm
- •History of mitral valve surgery
- •Severe mitral valve regurgitation
- •Inability to be treated with oral anticoagulation
- •Presence of intracardiac thrombi
- •Chronic obstructive pulmonary disease treated with long acting bronchodilatators
- •Obstructive sleep apnea syndrome
- •Pregnancy
- •Participation in other clinical studies
- •Unwilling to follow the study protocol and to attend follow-up visits
结局指标
主要结局
Arrhythmia Recurrence
时间窗: Day 91-365 after index ablation
Freedom from AF/AT
次要结局
- Incidence of periprocedural complications(day 0 - day 365)
- Number of electrical cardioversions and hospitalizations(day0 - day 365)