Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal Atrial Fibrillation Undergoing First Transcatheter Ablation Procedure of Atrial Fibrillation by Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Assess clinical and electrophysiological predictors of arrhythmic recurrence
研究概览
简要总结
From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.
详细描述
This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used.
The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with indication for AF ablation
- •Adequate anticoagulation therapy according to CHADs VASC
排除标准
- •patients who had already undergo an AF ablation procedure
- •Presence of intracavitary thrombus
- •Ejection fraction <35%
- •Pregnancy
- •Hematologic contraindications to ionizing radiation exposure
- •Congenital heart diseases
- •Cardiac Surgery < 1month
- •Uncontrolled heart failure
- •Valvular disease
- •Contraindications to general anesthesia
结局指标
主要结局
Assess clinical and electrophysiological predictors of arrhythmic recurrence
时间窗: through study completion, an average of 1 year
Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation.
次要结局
- Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies(through study completion, an average of 1 year)