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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Cardiologs Technologies
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Subjects with Cardiac Implantable Electronic Devices (CIED)
- •Pregnant or breast-feeding subjects
Outcomes
Primary Outcomes
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
Time Frame: 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
Secondary Outcomes
- 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)