Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.

Last updated: December 20, 2022
Sponsor: PulseAI Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT05668377
1
  • Ages 22-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 22 or older, able and willing to participate in the study
  • Patient admitted to hospital for ablation, cardioversion, or cardiacelectrophysiological exploration.
  • Patient who has read the information note and has given their consent before anyprocedure related to the study.

Exclusion

Exclusion Criteria:

  • Patient with a pacemaker, implantable defibrillator or cardiac resynchronisationtherapy device.

Study Design

Total Participants: 300
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2024

Study Description

Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.

The arrhythmias will include:

  • Atrial Fibrillation/Flutter

  • Tachycardia

  • Bradycardia

  • Premature Atrial Contractions

  • Premature Ventricular Contractions

Connect with a study center

  • Beacon Hospital Research Institute

    Dublin,
    Ireland

    Active - Recruiting

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