Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG in Subjects Hospitalized for Antiarrhythmic Drug Initiation and Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
研究概览
简要总结
The WatchQT study will compare the performance of a smartwatch combined with Cardiologs ECG AI Analysis system in monitoring corrected QT (QTc) intervals with that measured on a manually read 12-lead ECG in subjects with Normal Sinus Rhythm (NSR) during antiarrhythmic drug (AAD) initiation and follow-up at the hospital.
详细描述
The WatchQT Study is a prospective, non-significant risk, non-randomized, monocentric, open, comparative, concordance pilot study.
Under subject consent, subjects hospitalized for AAD initiation and monitoring will have smartwatch ECG recordings done simultaneously with 12-lead ECG measurements before and after drug administration twice a day, in accordance with the existing in-stay subject monitoring protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects over 22, able and willing to participate in the study
- •Subjects who are admitted to the hospital in NSR or AF and are eligible for AAD (class Ia or class III) dose initiation or re-initiation.
- •Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
排除标准
- •Subjects with Cardiac Implantable Electronic Devices (CIED)
- •Pregnant or breast-feeding subjects
结局指标
主要结局
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
时间窗: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Concordance between QTc intervals measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG for each measurement done during NSR. The Bazett (QTcB in ms) and Fridericia (QTcF in ms) methods will be used to correct QT intervals
次要结局
- Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Concordance between QTcB and QTcF intervals measured by the different methods(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Description of the QTc interval measurements in NSR(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Analysis of QT interval measured in subsets of subjects with and without wide QRS(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Quantitative analysis to determine the interobserver variability(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)
- Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG(Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization)