The South-Norway Atrial Fibrillation Screening Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1500
  • sponsor
    Sorlandet Hospital HF
Updated on 27 January 2021

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

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.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment AF screening
Clinical Study IdentifierNCT04700865
SponsorSorlandet Hospital HF
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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