NCT04700865

The South-Norway Atrial Fibrillation Screening Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Sorlandet Hospital HF · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AF screening	Continous ECG monitoring for minimum 3 days

Timeline

• Start date: 2020-12-23
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-01-08
• Last updated: 2022-12-05

Locations

1 site across 1 country: Norway