Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 8
- 主要终点
- Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
研究概览
简要总结
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).
Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
详细描述
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.
Outcomes:
- Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.
- Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins
- Occurrence of adverse events in each group post-procedure.
- Quality of life assessment at 6 and 12 months post-initial procedure.
Followup:
- 3, 6, and 12 months post-initial procedure.
- Clinical data, ECG, Holter, loop recorder at baseline and at each visit.
- QOL at baseline, 3, 6 and 12 months post-initial 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 or greater.
- •"high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
- •candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- •At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
- •continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation.
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial.
排除标准
- •chronic atrial fibrillation.
- •Patients with AF felt to be secondary to an obvious reversible cause.
- •inadequate anticoagulation as defined in the inclusion criteria.
- •left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
- •contraindications to systemic anticoagulation with heparin or coumadin.
- •previously undergone atrial fibrillation ablation.
- •left atrial size > 55 mm.
- •Patients who are or may potentially be pregnant
研究组 & 干预措施
PVI group
Trigger-based ablation guided by pulmonary vein antrum isolation
干预措施: Ablate AF triggers via PVI (Procedure)
CFAE group
Substrate-based ablation using an approach targeting CFAEs
干预措施: Substrate via CFAEs (Procedure)
Combined group
Combined trigger and substrate based approach
干预措施: Combined approach for AF ablation (Procedure)
结局指标
主要结局
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
时间窗: 3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
时间窗: 12 months
次要结局
- Fluoroscopy time at ablation.(At intervention)
- Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.(12 months)
- Procedure duration at ablation.(At intervention)
- Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.(12 months)
- Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.(12 months)
- Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.(12 months)