AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,350
- 试验地点
- 174
- 主要终点
- Atrial arrhythmias incidence
研究概览
简要总结
The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.
详细描述
The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (< or >40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188).
The same endpoint will be analyzed in sub populations (Sinus Node Disease and AVB) at 4 years follow up (n=4290).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.
排除标准
- •Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
- •Permanent or persistent atrial tachyarrhythmia
结局指标
主要结局
Atrial arrhythmias incidence
时间窗: 2 years
Two consecutive visits in which atrial fibrillation was present or - at least 22 hours of atrial fibrillation for at least 7 consecutive days or - at least 22 hours of atrial fibrillation per day for fewer than 7 consecutive days if an interruption by electrical or pharmacologic cardioversion occurred
% ventricular pacing
时间窗: 2 years
as measured in the device over the timeframe period
次要结局
未报告次要终点