NCT05161065

Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Cardiologs Technologies · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardiologs	Apple Watch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Timeline

• Start date: 2022-02-12
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2021-12-16
• Last updated: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study