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NCT04700865 Clinical Trial

The South-Norway Atrial Fibrillation Screening Study

Atrial Fibrillation Clinical Trial

— AFstudien  

Official title:
The South-Norway Atrial Fibrillation Screening Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04700865
Other study ID # 20/09000-7
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 23, 2020
Est. completion date June 30, 2022

Study information
Verified date December 2020
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• AF screening
Continous ECG monitoring for minimum 3 days

Locations
Country Name City State
Norway Sorlandet Hospital Arendal

Sponsors (1)
Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of AF AF during procedure During procedure
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