Smart Watches for the Diagnosis of Atrial Fibrillation in cardiac patients over 65

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001105134

Enrollment

130

Registered

2019-08-12

Start date

2019-11-01

Completion date

2020-03-01

Last updated

2021-02-16

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

Conditions

None listed

Brief summary

Sales of wearable technology have grown exponentially over the last few years. The latest generation devices promise the ability to diagnose a common abnormal rhythm, atrial fibrillation (AF) which is a leading cause of stroke. However, data on the accuracy of these diagnoses has not been validated in clinical trials. Our study aims to assess the accuracy of 2 commercially available smart watches for diagnosing AF compared to the gold standard 12 lead ECG. 200 participants will be recruited from the cardiology outpatient clinic. Those over 65 years of age will be included. Exclusion criteria will be: Participants <65 years, unable to provide consent, presence of pacemaker, non-ambulatory participants and those unable to record an ECG on the smart watch (eg. tremor, arthritis). Recordings will be taken from each watch and a 12 lead ECG acquired during the same session. The accuracy of each watch for diagnosing AF and sinus rhythm will be compared to the 12 lead ECG. A brief survey will also be given to each participant. Baseline characteristics including cardiovascular risk factors, history of arrhythmia's and medication use will be noted.

Interventions

Approximately 200 participants attending outpatient cardiology appointments will be recruited. Each participant will have a 12 lead ECG taken and also 30 second recordings from a smart watch. The smart watch rhythm diagnosis will be compared with the 12 lead ECG diagnosis, with a focus on the diagnosis of atrial fibrillation. A brief survey will also be conducted on each participant. Total duration of involvement is 30 minutes. The watch will be worn on either wrist.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

>65 years of age Participants at Eastern Health who are attending cardiology clinic

Exclusion criteria

<65years of age Participants not consenting for the study Participants with permanent pacemakers Participants that are not able to ambulate Participants inability to rest their fingers on the single lead ECG monitor (eg: patients with tremor, arthritis)

Outcome results