The South-Norway Atrial Fibrillation Screening Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: AF screening

• Registration Number: NCT04700865
• Lead Sponsor: Sorlandet Hospital HF

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-23
• Study First Submitted: 2020-12-26
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Examination	AF screening	Continuous ECG monitoring for minimum 3 days

Primary Outcome Measures

Name	Time	Method
Prevalence of AF	During procedure	AF during procedure

Trial Locations

Locations (1)

Sorlandet Hospital; 🇳🇴 Arendal, Norway