Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 602
- 试验地点
- 60
- 主要终点
- Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
研究概览
简要总结
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
The primary endpoint investigates the delay to implement treatment in two groups of patients :
- Active group: Patients followed by telecardiology.
- Control group: Patients followed in the conventional manner.
It is assumed that the delay to implement treatment will be higher in the Control group.
详细描述
Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.
This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).
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
- •Dual chamber pacemaker with activated Telecardiology
- •CHAD2DS2-VASc score ≥ 2
- •Sinusal rhythm at enrollment
- •Patient willing and able to comply with the protocol
- •Patient has provided informed consent
- •Men and women > 18 years-old
- •Patients geographically stable
排除标准
- •Anticoagulation therapy
- •Dual anti-platelet therapy
- •Class I or class III anti-arrhythmic drugs
- •Contraindication to antithrombotic therapy
- •Participation in another clinical study
- •Have a life expectancy < 6 months
结局指标
主要结局
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
时间窗: 12-month
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
次要结局
- Atrial burden at the end of the study(12-month)
- Number of patients with managed supraventricular arrhythmia(12-month)
- Serious adverse events related to supraventricular arrhythmia.(12-month)
- Atrial burden related to time(12-month)
- Supraventricular arrhythmia symptoms score (via a questionnaire)(at each follow-up visit)
- Supraventricular arrhythmia prevalence(12-month)
- Quality of Life (via the EQ-5D Questionnaire)(at each follow-up visit)