Atriale Vorhofsonde 1699 Mit Sehr Kurzem Bipolabstand Zur Vermeidung Von Far Field Sensing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 10
- 主要终点
- Incidence of inappropriate mode switch (documented by stored EGM's) using the atrial lead Tendril 1699T with short post ventricular atrial blanking period (PVAB) compared to standard atrial lead (Tentril 1388 or 1688) with optimised PVAB
研究概览
简要总结
The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking (PVAB).
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 the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (Study Group) eliminates the need for individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test in the Control Group with standard leads.
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 (ADX) DR or Victory or later pacemaker (St. Jude Medical)
- •Bipolar atrial pacing electrode
- •Age >= 18 years
排除标准
- •Persistent / permanent Atrial Arrhythmia
- •Pacemaker Revision
- •Pregnancy
- •Participation in another Study involving active implantable medical devices
- •Unable to complete follow up
- •Missing patient informed consent
- •Cardiac surgery or myocardial infarction within the last 4 weeks
- •Planned cardiac surgery within 3 months after enrollment
研究组 & 干预措施
1699T (Optisense)
Implantation of the Optisense Lead 1699T, programming of the shortest possible postventricular atrial blanking period (PVAB)
干预措施: pacemaker implantation (Device)
Standard lead
Implantation of a standard bipolar atrial pacing lead. Optimization of the postventricular atrial blanking period (PVAB) after implantation.
干预措施: pacemaker implantation (Device)
结局指标
主要结局
Incidence of inappropriate mode switch (documented by stored EGM's) using the atrial lead Tendril 1699T with short post ventricular atrial blanking period (PVAB) compared to standard atrial lead (Tentril 1388 or 1688) with optimised PVAB
时间窗: 1 and 3 months post implantation
次要结局
- 2:1 lock in of Atrial Flutter(1 and 3 months post implantation)
- Incidence of inappropriate mode switch in respect to lead position and ventricular stimulation frequency(1 and 3 months post implantation)
- Atrial Flutter in stored EGM's(1 and 3 months post implantation)