Efficacy and Stability of an Information and Communication Technology (ICT)-Based Centralized Monitoring System for Arrhythmia Detection After Atrial Fibrillation Ablation: a Prospective, Randomized Controlled, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The difference in arrhythmia detection rate
研究概览
简要总结
To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring system against the efficacy and stability of an existing outpatient-based electrocardiogram (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation ablation, and to test whether such continuous monitoring can better detect arrhythmia that is undetectable by existing methods and how this may affect treatment outcomes
详细描述
This clinical trial is a prospective, randomized, controlled, multicenter study in patients who are capable of using and consent to use a smartphone-based ECG monitoring after ablation for atrial fibrillation. The patients will be randomly assigned to either the Holter monitoring or ICT-based centralized clinical trial monitoring system group in a 1:1 ratio and will undergo monitoring from immediately after the procedure to 12 months after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years, but < 80 years
- •Patients with non-valvular atrial fibrillation
- •Patients with sustained atrial fibrillation despite ≥ 6 weeks of continuous antiarrhythmia therapy or those who underwent an ablation procedure for tachy-bradycardia syndrome within the previous week
- •Patients who can be followed-up for at least 3 months after ablation
- •Patients who can use and consent to use smartphone-based ECG monitoring
- •Patients who can use a smartphone (Android, version 5.0 or lower; development planned for version 6.0 or higher)
- •Those who can connect to the internet via LAN or WiFi and are in an environment where they can use a gateway and smartphone.
排除标准
- •Patients who cannot be monitored by a smartphone or Bluetooth device
- •Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age
- •Patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation
- •Patients belonging to a population vulnerable to clinical trials
结局指标
主要结局
The difference in arrhythmia detection rate
时间窗: 12 months
The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring
次要结局
- The difference in the number of hospital visits(12 months)
- The difference in the recurrence rate of atrial fibrillation or atrial tachycardia(12 months)