Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 650
- 试验地点
- 37
- 主要终点
- The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
研究概览
简要总结
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
The expected benefits will be a result of the reduction of the percentage of ventricular pacing.
It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.
The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
- •Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
- •Patient implanted with a bipolar right atrial lead and a right ventricular lead
- •Patient has signed a consent form after having received the appropriate information
排除标准
- •Patient with permanent AF
- •Patient suffering from sustained ventricular arrhythmias
- •Patient with congenital complete heart block
- •Patient with vasovagal syncope, carotid sinus syndrome
- •Patient with AV node ablation
- •Patient having suffered from a myocardial infarction within the last month
- •Patient suffering from severe aortic stenosis
- •Patient suffering from unstable angina pectoris
- •Patient is not able to understand the study objectives and protocol or refuses to co-operate
- •Patient is not available for scheduled follow-up
- •Patient has a life expectancy less than one year
- •Patient is included into another clinical study
- •Patient is minor, this is < 18 years
- •Patient is a pregnant woman
- •Any patient with a contra-indication for the device labeling
研究组 & 干预措施
1
AAIsafeR /SafeR Patient randomized with the SafeR switched ON
干预措施: Symphony DR 2550 and REPLY DR cardiac pacemakers (Device)
2
DDD(R) mode. Patients randomized with the SafeR mode switched OFF
干预措施: Symphony DR 2550 and REPLY DR cardiac pacemakers (Device)
结局指标
主要结局
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
时间窗: 3 years
次要结局
- Evolution of paroxysmal AV blocks(3 years)