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

Recruiting

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT05668377
• Lead Sponsor: PulseAI Ltd

Brief 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).

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 Timeline

• Study First Submitted: 2022-09-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-29
• Last Update Posted: 2022-12-29
• Study Start: 2023-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the performance of arrhythmia detection.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software	12 months	Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI neural network
Evalaute the performance of QTc interval measurement	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.

Trial Locations

Locations (1)

Beacon Hospital Research Institute; 🇮🇪 Dublin, Ireland