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

NCT ID: NCT05668377

Last Updated: 2022-12-29

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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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).

Detailed Description

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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

Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PulseAI ECG Platform

Cloud-based AI-enabled ECG analysis platform

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beacon Hospital Research Institute, Dublin, Ireland

UNKNOWN

Sponsor Role collaborator

PulseAI Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Burke, PhD

Role: PRINCIPAL_INVESTIGATOR

Beacon Hospital Research Institute, Dublin

Locations

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Beacon Hospital Research Institute

Dublin, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Alan Kennedy, PhD

Role: CONTACT

Phone: 07714640144

Email: [email protected]

Facility Contacts

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David Burke, PhD

Role: primary

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id