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

PulseAI

Status: Enrolling

Conditions: Arrhythmias, Cardiac

Treatments: Device: PulseAI ECG Platform

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05668377

1

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.