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

PulseAI Ltd300 enrolled

Overview

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).

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

300

Conditions

Arrhythmias, Cardiac

Interventions

PulseAI ECG PlatformDEVICE

Cloud-based AI-enabled ECG analysis platform

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beacon Hospital Research Institute

Dublin, Ireland

RECRUITING

Outcomes

Primary Outcomes

Evaluate the performance of arrhythmia detection.

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.

Time frame: 12 months

Secondary Outcomes

Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software

Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI neural network

Time frame: 12 months

Evalaute the performance of QTc interval measurement

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.

Time frame: 12 months

Central Contacts

Alan Kennedy, PhD

CONTACT

07714640144 alan.kennedy@pulseai.io

Data from ClinicalTrials.gov

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