Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14,726
- 试验地点
- 2
- 主要终点
- Latent atrial fibrillation
研究概览
简要总结
Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs > 20 beats, non-sustained AF/AFL.
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
- 40 Days 至 85 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the inpatient department or the outpatient department
- •Patients need to have at least one electrocardiogram within one year
排除标准
- •Diagnosis of atrial fibrillation/atrial flutter
- •History of atrial fibrillation/atrial flutter catheter ablation
- •Patients with cardiac implantable electronic devices
- •Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm
- •History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs
- •Any reasons indicate for anti-coagulant agents, including vitamin K antagonist and non-vitamin K antagonist oral anticoagulant
结局指标
主要结局
Latent atrial fibrillation
时间窗: Within 90 days after enrollment.
The primary outcome, latent atrial fibrillation, is a composite of new diagnoses of AF/AFL, atrial arrhythmia with high AF risk, including PACs ≥ 500/24hr, burst PACs \> 20 beats, and non-sustained AF/AFL, within 90 days after enrollment. The results will be demonstrated as the rate of diagnoses of latent atrial fibrillation.
次要结局
- Antiarrhythmic treatment(Within 180 days after enrollment.)
- 90-days New diagnoses of atrial fibrillation/atrial flutter(Within 90 days after enrollment.)
- Atrial arrhythmia with high AF risk(Within 90 days after enrollment.)
研究者
Chin Lin
Associate Professor
National Defense Medical Center, Taiwan