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NCT05668377 Clinical Trial

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

Arrhythmias, Cardiac Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05668377
Other study ID # 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date January 1, 2024

Study information
Verified date December 2022
Source PulseAI Ltd
Contact Alan Kennedy, PhD
Phone 07714640144
Email alan.kennedy@pulseai.io
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• PulseAI ECG Platform
Cloud-based AI-enabled ECG analysis platform

Locations
Country Name City State
Ireland Beacon Hospital Research Institute Dublin

Sponsors (2)
Lead Sponsor Collaborator
PulseAI Ltd Beacon Hospital Research Institute, Dublin, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary 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 12 months
Secondary 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. 12 months
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