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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

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