REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
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
- •Patients with symptomatic non-valvular AF or AT recurrences despite of one previous PVI (+/- cavotricuspid isthmus ablation) catheter ablation for AF.
- •Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
排除标准
- •Patients with contraindications to catheter ablation or inability to provide informed consent Patients who underwent PVI + (ablation of additional RA/LA substrates/areas) Patients who did not undergo PVI before Patients who underwent more than one prior PVI/Re-PVI Patients with left atrial size > 55mm Patients with longstanding persistent AF > 12 months duration Prior surgical AF ablation Contraindications for repeat ablation Prior implantable loop recorder History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease or Asthma treated with long acting bronchodilatators Obstructive sleep apnea syndrome requiring CPAP mask ventilation Pregnancy Participation in other clinical studies Unwilling to follow the study protocol and to attend follow-up visits
研究组 & 干预措施
CF-guided RFC: Re-PVI and substrate modification of low voltage areas
Patient get intervention via Contact force guided radiofrequency ablation
干预措施: CF-guided RFC: Re-PVI and substrate modification of low voltage areas (Procedure)
Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath
Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9)
干预措施: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas (Procedure)
结局指标
主要结局
Primary Endpoint
时间窗: Within the study duration of 1 Year
Complete re-pulmonary vein isolation (re-PVI), Bidirectional conduction block across linear lesions, Complete substrate elimination (defined as: voltage abatement and/or loss of capture).
次要结局
未报告次要终点