Feasibility and Reliability of Smart Watch iECG for the Detection of Cardiac Arrhythmias (The Leipzig Apple Heart Rhythm Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results
研究概览
简要总结
This study aims to assess the feasibility and reliability of smart watch iECG provided by the Apple Watch/Apple iPhone for the detection of different cardiac arrhythmias. In this study, results from a 12-lead ECG will be set as the gold standard for the arrhythmia diagnosis, and results from the smart watch iECG (Apple watch/Apple iPhone application and Cardiologist's interpretations) as the index tests. The iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application.
详细描述
This diagnostic accuracy study is an investigator-initiated trial to evaluate the value of a smart watch-based iECG for detection of cardiac arrhythmias.
iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the market version of the ECG application (Apple Inc., California). Participants will be advised to lie down in a supine position and breathe spontaneously. All recording will be done by trained study personnel.
All iECG and 12-lead ECG recordings will be presented in PDF format as our references. Saved formats will be transferred to our Telemonitoring Center for further analysis and processing.
Results from a 12-lead ECG will be considered as the gold standard for the measurement of heart rhythms and the arrhythmia diagnosis. All 12-lead ECGs recordings will be analyzed by 2 blinded cardiologists and will be categorized as "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, cardiologists will report ECG wave's characteristics as well as any other possible diagnosis including "Superior ventricular tachycardia", "Ventricular tachycardia", "Atrial flutter", and "other types: other possible arrhythmias". In the case of uncertainties, a third cardiologist will be consulted, blinded for initial diagnoses.
The iECG recordings (test index) will be interpreted and reported in two different ways:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged≥22 years at the time of eligibility screening will be included.
- •Patients with known cardiac arrhythmias; i.e. AF before and after cardioversion, hemodynamically stable Bradycardias, SVT and VT during EP procedures and implants can also be included
排除标准
- •Pregnancy
结局指标
主要结局
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results
时间窗: Baseline
Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results
时间窗: Baseline
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG
时间窗: Baseline
次要结局
- Proportion of interpretable and non-interpretable iECGs(Baseline)
- Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: cardiologists interpretation of iECG (index test) and 12-lead ECGs (reference test)(Baseline)
- Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG(Baseline)
- Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: ECG App interpretation results (index test) and 12-lead ECGs (reference test)(Baseline)