Continuous monitoring of heart rhythm with a wearable device for detection of atrial fibrillation.

Development and validation of a novel, wearable continuous ECG monitor for automated detection of atrial fibrillation in patients attending a hypertension outpatient clinic.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617001374358

Enrollment

Registered

2017-09-27

Start date

2018-04-10

Completion date

2018-12-01

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

Our goal is to produce automated continuous, real time ECG interpretation with artificial intelligence (AI), utilising our wristwatch-sized ECG machine. Our initial AI system will be focused on automated detection of atrial fibrillation. We have already developed a prototype ECG detection device and trained our initial AI system, which has undergone validation testing in a clinical environment. This study is intended to further develop our ECG system to be suitable for more widespread use.

Interventions

Participants will be exposed to 24 hours of monitoring with a wearable ECG device. The Alerte Digital Health ECG device is a small wrist watched sized device with two electrodes attached to their body. The device comprises of circuitry allowing live streaming to a smartphone via Bluetooth, and a rechargeable battery with approximate life of 24 hours. It has been developed to provide automated continuous, real time ECG interpretation with artificial intelligence and it has been configured for this study to focus on automated detection of atrial fibrillation. The device has previously been validated for safety and accuracy in a laboratory environment, and subsequently in a clinical environment compared against a standard ward based hospital monitoring system.

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

Age over 18 and less than 80 years. Ability to give informed consent in English without the need for a translator. Attendance at the Royal Perth Hospital hypertension clinic. Presence of sinus rhythm or atrial fibrillation. Willingness to return devices to Royal Perth Hospital hypertension clinic.

Exclusion criteria

Permanent pacemaker or defibrillator. Presence of arrhythmias other than atrial fibrillation on baseline ECG. (Presence of ventricular ectopy is not an exclusion criteria). Dementia or severe physical dependence. Inability to attend on two consecutive days to allow for return of the monitoring system, or other social circumstances in which an ECG system and smart phone may not be practical.

Outcome results