Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Atrial high rate/Automatic mode switch episodes
研究概览
简要总结
This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Sick sinus syndrome patients having dual-chamber pacemaker
- •Having paroxysmal AF defined as at least 2 episodes of AHR/AMS >190 b/min lasting >6 minutes
- •Having normal atrioventricular conduction
排除标准
- •Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)
- •History of acute coronary syndrome
- •Significant heart valve disease
- •Chronic AF before randomization
- •Overt heart failure
- •Malignancy
- •Any reasons for antiarrhythmic medication use
- •Inability to follow patients every 3 months
研究组 & 干预措施
High Atrial Base Rate Pacing
The base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch
干预措施: HBR (Device)
Device Default
The base rate of pacemaker will be determined 60 beats/minute
干预措施: DD (Device)
结局指标
主要结局
Atrial high rate/Automatic mode switch episodes
时间窗: During 6 Months
The number of AHR/AMS episodes recorded by pacemaker
次要结局
- Stroke(During 6 months)
- Myocardial infarction(During 6 months)
- Worsening Functional Class(During 6 months)
- Death(During 6 months)
- Heart failure(During 6 months)
研究者
Chancellor of research
Vice-Chancellor for Research in UMSU
Urmia University of Medical Sciences