Clinical trial NCT04700865: The South-Norway Atrial Fibrillation Screening Study
Official title: The South-Norway Atrial Fibrillation Screening Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2021-01-08
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF

Detailed description: Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke. Many AF cases are undiagnosed due to the asymptomatic and intermittent nature of AF (silent AF). Today there is no simple and inexpensive method of detecting silent AF and thus preventing stroke. The ECG247 Sensor is a new Norwegian digital clinical tool for out-of-hospital self-testing of AF. The innovation project has originated from the University of Agder and Sorlandet Hospital. The COVID19 pandemic is realizing more than ever the need for single-use self-testing out-of-hospital diagnostic tools.

The general aim of this open non-randomized study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF in a cohort of 1500 65-year-old individuals with additional risk factors for stroke.

If the study results indicate that easy-to-use continuous AF-screening-devices designed for self-testing can identify people with previously unrecognized AF, this study may contribute to change the approach to screening for AF in the community. Consequently, the study may prevent stroke in the future. By preventing stroke, major personal and socio-economic consequences can be avoided.

Eligibility criteria: Inclusion Criteria:

* Age \>65 years
* Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor)
* Informed written consent for participation

Exclusion Criteria:

* Chronic AF
* Lack of ability to cooperate

Primary outcomes:
measure: Prevalence of AF
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital
Study officials:
affiliation: Sorlandet Hospital Arendal
name: Jarle Jortveit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jortveit J, Fensli R. Remote ECG Monitoring by ECG247 Smart Heart Sensor. Int J Telemed Appl. 2022 Feb 11;2022:6812889. doi: 10.1155/2022/6812889. eCollection 2022.
citation: Sandberg EL, Grenne BL, Berge T, Grimsmo J, Atar D, Halvorsen S, Fensli R, Jortveit J. Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology. J Healthc Eng. 2021 Nov 2;2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.