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The South-Norway Atrial Fibrillation Screening Study (AFstudien)

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ClinicalTrials.gov Identifier: NCT04700865
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: AF screening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The South-Norway Atrial Fibrillation Screening Study
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Examination
Continuous ECG monitoring for minimum 3 days
Diagnostic Test: AF screening
Continous ECG monitoring for minimum 3 days




Primary Outcome Measures :
  1. Prevalence of AF [ Time Frame: During procedure ]
    AF during procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700865


Contacts
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Contact: Jarle Jortveit, PhD +4799450714 jarle.jortveit@sshf.no

Locations
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Norway
Sorlandet Hospital Recruiting
Arendal, Norway, 4809
Contact: Jarle Jortveit, PhD    +4799450714    jarle.jortveit@sshf.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Principal Investigator: Jarle Jortveit, PhD Sorlandet Hospital Arendal
Additional Information:
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Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT04700865    
Other Study ID Numbers: 20/09000-7
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes