Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias Who Need Cardiac Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 12
- 主要终点
- Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
研究概览
简要总结
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to the German guidelines. Medication is controlled throughout the study with a beta-blocker as the only antiarrhythmic drug.
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
- 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
- •Indication for cardiac pacing according to the German guidelines
- •Documented (electrocardiogram; ECG) atrial arrhythmia during the last three months before enrollment
- •Willingness to terminate antiarrhythmic drugs until the first recurrence of an atrial arrhythmia
- •Sinus rhythm during 24 hours before implant of the device
排除标准
- •Ejection fraction below 40%
- •Mechanic prosthesis of the tricuspid valve
- •Indication to implantable cardioverter defibrillator (ICD)-implantation
- •Pregnancy
研究组 & 干预措施
Control Arm
Algorithms for prevention and termination of AF not activated
Prevention and Therapy Algorithms on
Activation of preventive and therapeutic algorithms
干预措施: Activation of preventive and therapeutic algorithms for treatment of AF (Device)
Prevention and Therapy Algorithms on
Activation of preventive and therapeutic algorithms
干预措施: AF Prevention and Therapy Algorithms On (Device)
结局指标
主要结局
Incidence of symptomatic and/or persistent re-occurrences of atrial arrhythmias
时间窗: 2 years
Time to first re-occurrence of first symptomatic or persistent atrial arrhythmia
时间窗: 2 years
次要结局
- Quality of life(2 years)
- Atrial fibrillation (AF)-burden(2 years)
- Time interval between persistent episodes during the follow-up period(2 years)
- Reduction of the total amount of tachyarrhythmias stored in the event counter of the implanted device(2 years)
- Necessity and date of a specific antiarrhythmic therapy and/or prescription of antiarrhythmic drugs class I and II(2 years)
- Evaluation of possible atrial proarrhythmic effects of the termination algorithms(2 years)
- Cost-efficiency(2 years)
- Incidence in different pacing modes [AAI, DDD(R)](2 years)