Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 4
- 主要终点
- Freedom from atrial arrhythmias, lasting more than 30 sec.
研究概览
简要总结
The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation (AF) ablation outcomes.
详细描述
Atrial fibrosis is a hallmark of the AF substrate. An accurate identification and localization of myocardial fibrosis areas prior to an ablation procedure by means of LGE-MRI might help to target atrial areas harboring AF, thereby improving ablation outcomes and reducing AF recurrences.
In order to test this hypothesis, we will conduct a randomized study comparing the isolation of pulmonary veins without fibrosis imaging (conventional ablation procedure) vs. isolation of the pulmonary veins and pathological (fibrotic) tissue with the aid of LGE-MRI. Fibrotic tissue patches will be encircled and isolated in all patients in the active arm; furthermore, LGE-MRI will be used to identify, locate and guide ablation catheter to anatomical gaps surrounding pulmonary veins in re-do procedures.
Eventually, we will identify an optimized ablation strategy in patients undergoing AF radiofrequency ablation on the basis of left atrium (LA) fibrosis characterization.
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
- •Patients undergoing a first or subsequent ablation procedure.
- •Pre-procedural 3 Tesla LGE-MRI.
- •Referred for radiofrequency ablation of pulmonary veins (paroxysmal, persistent or long-standing AF).
- •Signed informed consent.
排除标准
- •Claustrophobia.
- •Refusal to participate in the study.
- •Presence of atrial thrombus.
- •LA anteroposterior diameter >55 mm.
- •Major renal impairment.
- •Contrast allergy.
- •Pregnancy.
结局指标
主要结局
Freedom from atrial arrhythmias, lasting more than 30 sec.
时间窗: 1 year
Recurrence is defined as any documented episode of AF/atrial tachycardia lasting more than 30 seconds, after a blanking period of 3 months.
次要结局
- Total time of radiofrequency application(During procedure)
- Total X-ray time(During procedure)
研究者
Josep Lluis Mont Girbau
MD PhD
Hospital Clinic of Barcelona