NCT00286858已完成不适用
Clinical Observations of Automatic Algorithms for Cardiac Pacing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 903
- 试验地点
- 40
- 主要终点
- Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
研究概览
简要总结
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.
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
- •Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.
排除标准
- •Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
结局指标
主要结局
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
时间窗: At 12 Months
% Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.
次要结局
未报告次要终点
研究者
研究点 (40)
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