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

December 20, 2022 updated by: PulseAI Ltd
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Beacon Hospital Research Institute
        • Contact:
          • David Burke, PhD
        • Principal Investigator:
          • David Burke, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants hospitalised for ablation, cardioversion or cardiac rhythm consultation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the performance of arrhythmia detection.
Time Frame: 12 months
Evaluate the performance of arrhythmia detection by the PulseAI neural network applied to ECG data collected via the Smartwatch compared to physicians' interpretation of the 12-lead ECG.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software
Time Frame: 12 months
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI neural network
12 months
Evalaute the performance of QTc interval measurement
Time Frame: 12 months
Evaluate the performance of QTc interval measurement by the PulseAI neural network applied to the Smartwatch ECG data compared to physicians' measure of the QTc interval from the 12-lead ECG.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PulseAI Ltd

Collaborators

Beacon Hospital Research Institute, Dublin, Ireland

Investigators

  • Principal Investigator: David Burke, PhD, Beacon Hospital Research Institute, Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Estimate)

December 29, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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