Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Ablation success
研究概览
简要总结
Rationale:
Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.
Objectives:
To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.
Study design:
Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.
Study population:
Patients aged 18 years and older with documented AF, scheduled for AF ablation.
Main study endpoints:
Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older;
- •Documented atrial fibrillation;
- •Scheduled for AF ablation or redo AF ablation;
- •Able and willing to provide written informed consent.
- •Exclusion criteria
- •Serious patient condition before ablation;
- •Physically or mentally unable to provide written informed consent.
排除标准
- 未提供
结局指标
主要结局
Ablation success
时间窗: 12 months
Ablation success is defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted. Atrial arrhythmias are AF, atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on ECG or Holter monitoring.
次要结局
- Disease progression to persistent or permanent AF.(24 months)
- Time to recurrence of AF or atrial arrhythmia after the blanking period(24 months)
- Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period.(3 months)
- Use of antiarrhythmic drugs (AADs) one year after ablation.(12 months)
- Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.(12 months)
- Number of veins with pulmonary vein reconnection at redo procedure.(24 months)