Prospective Multicenter Observation Study on the Association Between the Severity of Device-detected Sleep-disordered Breathing and the Risk of Cardiac Arrhythmic Events
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 14
- 主要终点
- Number of participants with atrial fibrillation
研究概览
简要总结
This prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.
详细描述
The prevalence of SDB high in patients with cardiac implantable electronic device (CIED). Recently, device-detected SDB events showed a correlation with sleep-disordered breathing (SDB) diagnosed by polysomnography. Thus, CIED will facilitate early detection and monitoring of SDB in patients with CIEDs. Few studies investigated prognostic value of CIED-detected SDB in risk of cardiovascular events. Therefore, the primary aim is to determine whether device-detected SDB are associated with increased risk of cardiac arrhythmias or other cardiovascular morbidities using a prospective multicenter registry.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 19years
- •CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female
排除标准
- •CIED without atrial lead
- •persistent or permanent atrial fibrillation (AF) or flutter
- •history of catheter of surgical ablation of AF
- •valvular steno-insufficiency more than moderate degree
- •chronic obstructive pulmonary disease
- •under current treatment for sleep-disordered breathing
- •life expectancy < 1year
结局指标
主要结局
Number of participants with atrial fibrillation
时间窗: from enrollment to last follow-up (2 years)
cardiac implantable electronic device-detected or clinical atrial fibrillation
次要结局
- Number of participants with ventricular arrhythmia(from enrollment to last follow-up (2 years))
- Number of participants with complications associated with atrial fibrillation(from enrollment to last follow-up (2 years))