Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Low voltage area
研究概览
简要总结
Atrial fibrillation (AF) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. Progression of AF is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and AF itself. This results in complex electrical conduction disorders, which is defined as electropathology. The aim of our study is to evaluate whether an artificial intelligence (AI)-enabled ECG algorithm (on an ECG in Sinus Rhythm) can predict electropathology in patients with AF who undergo a first PVI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Provide signed and dated informed consent.
- •First PVI-procedure
- •Age is 18 years or higher.
- •12-lead ECG available in SR during the last 14 days.
排除标准
- •Mitral insufficiency of grade 3 or
- •Participating in another study that may interfere with participation in this study
结局指标
主要结局
Low voltage area
时间窗: During atrial voltage mapping, prior to PVI procedure.
Proportion of low voltage area in the left atrium. (Defined as a threshold 0.5mV)
次要结局
- Conduction delay score(During atrial voltage mapping, prior to PVI procedure.)
- Conduction delay(During atrial voltage mapping, prior to PVI procedure.)
- Left atrial size(Prior to PVI procedure.)
- Transition zone voltage area(During atrial voltage mapping, prior to PVI procedure.)
- Total LA conduction time(During atrial voltage mapping, prior to PVI procedure.)
- Left atrial appendage ejection velocity.(Immediately prior to PVI procedure.)
- Pericardial adipose tissue volume(Prior to PVI procedure.)
- Conduction time from sinus node to Bachman bundle(During atrial voltage mapping, prior to PVI procedure.)
研究者
Laurent Pison
Clinical professor
Ziekenhuis Oost-Limburg