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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-12

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiologs

Apple Watch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Intervention Type DEVICE

Other Intervention Names

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Apple Watch

Eligibility Criteria

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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