The South-Norway Atrial Fibrillation Screening Study (AFstudien)

December 2, 2022 updated by: Sorlandet Hospital HF
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Arendal, Norway, 4809
        • Sorlandet hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Examination
Continuous ECG monitoring for minimum 3 days
Diagnostic test: AF screening
Continous ECG monitoring for minimum 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of AF
Time Frame: During procedure
AF during procedure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Jarle Jortveit, PhD, Sorlandet Hospital Arendal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 23, 2020

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

December 26, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (ACTUAL)

January 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/09000-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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