Clinical trial NCT05161065: Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Cardiologs Technologies
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 to 50 Subjects: Subjects who are being hospitalized for antiarrhythmic drug (AAD) initiation and monitoring per standard of care.

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects over 22, able and willing to participate in the study
2. 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.
3. 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:

1. Subjects with Cardiac Implantable Electronic Devices (CIED)
2. Pregnant or breast-feeding subjects

Primary outcomes:
measure: Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Secondary outcomes:
measure: Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Concordance between QTcB and QTcF intervals measured by the different methods
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Description of the QTc interval measurements in NSR
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Quantitative analysis to determine the interobserver variability
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
measure: Analysis of QT interval measured in subsets of subjects with and without wide QRS
timeFrame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jagmeet Singh, MD ScM DPhil
role: PRINCIPAL_INVESTIGATOR
References: