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

NCT05161065 | Completed FDA Device

• 1 other identifier: WatchQT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

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

  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

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

Secondary Outcomes (7)

• Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI

  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

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

• Description of the QTc interval measurements in NSR

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

• Quantitative analysis to determine the interobserver variability

  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

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

Interventions

Cardiologs DEVICE

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

Also known as: Apple Watch

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects with Cardiac Implantable Electronic Devices (CIED)
• Pregnant or breast-feeding subjects

Sponsors & Collaborators

• Cardiologs Technologies: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Jagmeet Singh, MD ScM DPhil

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 16, 2021
• Study Start: February 12, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)