An observational study in Atrial Fibrillation, sponsored by Cardiologs Technologies. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Cardiologs Technologies · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 50 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cardiologs Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
30 to 50 Subjects: Subjects who are being hospitalized for antiarrhythmic drug (AAD) initiation and monitoring per standard of care.
Exclusion Criteria:
Apple Watch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
Also known as: Apple Watch
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
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
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI in determining subjects at risk of AAD induced ventricular arrhythmia compared to that identified by manually read 12-lead ECG in subjects with a prolonged QTc \> 500 ms and/or subjects with a QTc prolongation of \> 15% after their initial AAD dose
Time frame: 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
Concordance between QTcB and QTcF intervals measured by the different methods (smartwatch combined with Cardiologs AI, smartwatch read manually, 12-lead read manually, lead 1 from 12-lead read manually and automated interpretation of the 12 lead ECG machine)
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the QTc interval measurements in NSR
Description of the QTc interval measurements in NSR as a function of timepoints by the different methods
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Quantitative analysis to determine the interobserver variability
Quantitative analysis to determine the interobserver variability in QTc interval measurements by the smartwatch and 12-lead ECG manual readings
Time frame: 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
Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
Time frame: 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
.Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG at each timepoint and overall.
Time frame: 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
Patient with wide QRS is determined as a QRS\>120ms at D0 from automated interpretation of the 12-lead ECG machine. The analysis will be done in subset of 2 groups according to the QRS measured as wide or not machine
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Cardiologs Technologies