Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 36
- 主要终点
- Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
研究概览
简要总结
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
详细描述
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Experiencing at least one (1) documented episode of spontaneous persistent or paroxysmal atrial fibrillation during the last 3 months by rhythm strip/ECG.
- •One (1) previous AF ablation (PVI-only - any technology) after Jan-01-2013, but NOT within the last 3 months.
- •Left atrial diameter < 6.0 cm via transthoracic echo or transesophageal echo; or <6.5 cm via CT or MRI with 6 months prior to the procedure.
- •Sustained spontaneous or induced AF (>5 min uninterrupted).
排除标准
- •Presence of structural heart disease with clinical significance
- •NYHA Class IV
- •Ejection fraction < 35%
- •Previous AF ablation within the last 3 months
- •ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
- •History of myocardial infarction (MI) within the past three (3) months
- •Atrial clot/thrombus noted within 72 hours of the procedure
结局指标
主要结局
Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
时间窗: 12 months post procedure
Single procedure freedom from recurrence from 3-12 months post procedure
Freedom From Serious Adverse Events Related to the Procedure
时间窗: 12-month post procedure
Freedom from any procedure-related serious adverse event from 0-12 months post procedure
次要结局
未报告次要终点