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Completed

NCT Number: NCT05161065

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiologs

Device

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

Other names: Apple Watch

Primary outcomes

  1. 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

  1. Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI

    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 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

  2. Concordance between QTcB and QTcF intervals measured by the different methods

    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 (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)

  3. Description of the QTc interval measurements in NSR

    Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization

    Description of the QTc interval measurements in NSR as a function of timepoints by the different methods

  4. Quantitative analysis to determine the interobserver variability

    Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization

    Quantitative analysis to determine the interobserver variability in QTc interval measurements by the smartwatch and 12-lead ECG manual readings

  5. 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

    Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI

  6. Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG

    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 at each timepoint and overall.

  7. Analysis of QT interval measured in subsets of subjects with and without wide QRS

    Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization

    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

Sponsors and collaborators

Lead sponsor

Cardiologs Technologies

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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