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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05668377

Enrollment

300

Registered

2022-12-29

Start date

2023-01-01

Completion date

2024-01-01

Last updated

2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

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

Interventions

DEVICEPulseAI ECG Platform

Cloud-based AI-enabled ECG analysis platform

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Ireland

Contacts

Primary ContactAlan Kennedy, PhD

alan.kennedy@pulseai.io07714640144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026