Far Field Sensing Test Study in Patients With Implanted Cardiac Dual Chamber Pacemakers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Incidence of inappropriate mode switch due to far field R-wave sensing
研究概览
简要总结
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.
详细描述
Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test is effective in avoiding inappropriate mode switch due to FFS when compared to standard programming of the PVAB
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
- Single (Participant)
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
- •Indication for dual chamber pacing
- •Implantation of an Identity DR pacemaker (St. Jude Medical)
- •Bipolar atrial pacing electrode
排除标准
- •Heart failure NYHA III and IV
- •Unstable angina pectoris
- •Indication for the implantation of an ICD
- •Cardiac surgery within previous 6 months
- •Cardiac surgery planed for the next 3 months
研究组 & 干预措施
1
Optimization of the postventricular atrial blanking period to avoid far-field R-wave sensing.
干预措施: Individualized Programming of PVAB (Device)
2
Programming of the nominal setting for the post-ventricular atrial blanking period (100 ms)
干预措施: Nominal PVAB (Device)
结局指标
主要结局
Incidence of inappropriate mode switch due to far field R-wave sensing
时间窗: 3 months
次要结局
- Incidence of inappropriate mode switch due to far field R-wave sensing in relation to the lead position(3 months)