Study on the Effectiveness of Atrial Fibrillation Analysis Software in Atrial Fibrillation Rhythm Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- The ECG and PPG data are automatically analyzed by the AF analysis software.
研究概览
简要总结
Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in patients with AF.
In this study, the AF patients will wear an watch and ECG patch to continuously monitor ECG and PPG. The software uses an integrated diagnostic mechanism of "AF burden + AF segments" to efficiently analyze ECG and PPG data, which can quickly and accurately identify the occurrence of AF and analyze AF burden in real-time, facilitating physicians' diagnosis and treatment and efficacy assessment.
详细描述
PPG-AF study is a Cohort randomized observational study.The trial will include patients with AF who meet the study requirements from Beijing Anzhen Hospital within 2 months. Each participant will wear an watch and ECG monitor after admission to hospital until Radiofrequency ablation for AF, and after AF ablation until discharge. And more than 18 hours in each period.
- Primary endpoint. The ECG and PPG data are automatically analyzed by the AF analysis software. The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.
- Secondary endpoints. The AF burden calculated from PPG data is compared with that from ECG monitoring, to verify the feasibility of daily monitoring of AF burden using PPG analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age.
- •Have clear ECG-recorded atrial fibrillation in the past and will undergo atrial fibrillation ablation in the current hospitalization.
- •Patients who agree to wear both the watch and the ECG recorder.
排除标准
- •Inability to wear the watch due to limited mobility or other problems.
- •Severe skin diseases such as skin allergies or skin ulcers.
- •Chronic insomnia not treated with medication.
- •Patients with severe cardiovascular disease who may be resuscitated at any time.
- •Previous history of Parkinson's, schizophrenia, epilepsy.
- •Black people and those with excessively dark skin.
结局指标
主要结局
The ECG and PPG data are automatically analyzed by the AF analysis software.
时间窗: Two months after enrollment of the first subject
The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.
次要结局
- The AF burden calculated from PPG data is compared with that from ECG monitoring.(Two months after enrollment of the first subject)
研究者
Chang sheng Ma
Center Director
Beijing Anzhen Hospital