A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Time to first episode of AF>6 min detected by the pacemaker
研究概览
简要总结
Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF.
The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF.
- •Age ≥18 years.
- •Patient informed consent.
排除标准
- •Permanent or persisting (>7 days) AF prior to implantation.
- •Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring).
- •Life expectancy <2 years.
- •Participation in another interventional research study.
- •Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
- •Pregnancy.
结局指标
主要结局
Time to first episode of AF>6 min detected by the pacemaker
时间窗: Within two years
First episode of AF \> 6 min detected by the device
次要结局
- QOL(After 12 months)
- Time to first episode of AF>24 hours detected by the pacemaker(Within two years)
- Time to stroke, transient ischemic attack (TIA), or thromboembolic event(Within two years)
- Time to death(Within two years)
- Time to first episode of AF>6 hours detected by the pacemaker(Within two years)
- 6MHWT(After 12 months)
- Time to direct current (DC) cardioversion or medical cardioversion for AF(Within two years)
- Time to need for reprogramming of the pacing rate (cross-over)(Within 2 years)
研究者
Jens Cosedis Nielsen
Jens Cosedis Nielsen, professor, MD, DMSc, PhD
Aarhus University Hospital