Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- recurrence of AF
研究概览
简要总结
Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF), however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA) reconnection, the cause of recurrence has been not yet fully clarified.
The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients.
According to the previous reports, heart rate (HR) increased, and heart rate variability (HRV) reduced after PVI. These are considered to be due to "autonomic denervation" caused by catheter ablation of GP.
For the best of investigators knowledge, there have been no data on heart rate turbulence (HRT) of baroreflex sensitivity (BRS) concerning PVI.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo PVI for paroxysmal atrial fibrillation
- •Patients in sinus rhythm at baseline
排除标准
- •prior left atrial Ablation
- •left atrial diameter >55mm
- •frequent atrial extrasystole, frequent ventricular Extrasystole
- •Diabetes Mellitus
- •sleep apnea syndrome
结局指标
主要结局
recurrence of AF
时间窗: 12 months
Time measured in days to recurrence of AF
次要结局
- effect of PVI on cardiac autonomic system utilizing BRS measurement(12 months)
- effect of PVI on cardiac autonomic system utilizing HRT measurement(12 months)
- association between measured parameters (HRT, BRS) and the recurrence of AF(12 months)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf