NCT01912326已完成不适用
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- Reduction of AT/AF Burden in the pacemaker diagnostics
研究概览
简要总结
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
Hypothesis:
Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.
详细描述
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for dual chamber pacemaker
- •documented paroxysmal or persistent Atrial Fibrillation
- •P-wave >1.0 mV in Sinus Rhythm or sufficient detection of AFib
- •stable antyarrhythmic therapy
- •age >= 19 years
- •written informed consent
- •implantation of a Identity DR 5370/5376 or later
- •bipolar atrial lead
排除标准
- •permanent AFib
- •reversible etiology of AFib
- •HYHA II or IV
- •Coronary Artery disease with stable angina pectoris
- •implanted ICD or planned implantation of a ICD
- •cardiac surgery within the last 6 months or planned within 12 months
- •live expectancy < 12 months
- •pregnancy
研究组 & 干预措施
AF Suppression On
Active Comparator
AF Suppression Algorithm On, optimized AF Pacemaker Programming
干预措施: Pacemaker Implantation (Device)
AF Suppression Off
Active Comparator
AF Suppression programmed Off, Optimized Pacemaker Programming
干预措施: Pacemaker Implantation (Device)
结局指标
主要结局
Reduction of AT/AF Burden in the pacemaker diagnostics
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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