OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Number of undersensing of paroxysmal AF and AT from Holter recording.
研究概览
简要总结
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).
详细描述
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.
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
- 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 with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
- •Signed informed consent
- •Age >18 yrs
排除标准
- •Severe valvular heart disease (echocardiogram less than 6 months old)
- •Angina Pectoris class ≥ III
- •Congestive heart failure - NYHA class ≥ III
- •Left Ventricular Ejection Fraction < 35% (less than 6 months old)
- •Hypertrophic Cardiomyopathy
结局指标
主要结局
Number of undersensing of paroxysmal AF and AT from Holter recording.
时间窗: 1-3 months
次要结局
- Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.(1-3 months)