Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 20
- 主要终点
- Ventricular pacing percentage
研究概览
简要总结
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients over 18 years of age;
- •Patient has proven informed consent;
- •Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
- •Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;
- •Stable medical situation;
- •Stable geographical situation;
排除标准
- •Permanent or paroxysmal AV block ≥ II;
- •Permanent Atrial fibrillation/Atrial flutter;
- •Device Replacement;
- •Patient with a poor echocardiographic window;
- •Patient already implanted with the right ventricular lead not in the apical position;
- •Subjects with a dual chamber pacemaker, implanted later than six months;
- •Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
- •Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
- •VpS or IRSplus algorithm contraindications;
- •Age < 18 years;
- •Life expectancy < 12 months;
- •Cardiac surgery planned within the FU period;
- •Participation to another clinical investigation;
研究组 & 干预措施
Ventricular Pace Suppression (VpS)
The function Ventricular Pace Suppression (VpS) is activated
干预措施: Ventricular Pace Suppression (Vps) (Other)
Intrinsic Rhythm Support (IRSplus)
The function Intrinsic Rhythm Support (IRSplus) is activated
干预措施: Intrinsic rhythm support (IRSplus) (Other)
结局指标
主要结局
Ventricular pacing percentage
时间窗: 6 months
次要结局
- Burden of atrial fibrillation(6 Months)
- Long-term atrio-ventricular conduction delay(6 Months)
- Occurrence of atrial tachycardia or atrial fibrillation events(6 Months)