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AFstudien: The South-Norway Atrial Fibrillation Screening Study

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT04700865
Collaborator
(none)
1,500
Enrollment
1
Location
1
Arm
48.3
Anticipated Duration (Months)
31.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: AF screening
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Dec 23, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Examination

Continuous ECG monitoring for minimum 3 days

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of AF [During procedure]

    AF during procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sorlandet Hospital Arendal Norway 4809

Sponsors and Collaborators

  • Sorlandet Hospital HF

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT04700865
Other Study ID Numbers:
  • 20/09000-7
First Posted:
Jan 8, 2021
Last Update Posted:
Jan 8, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Jan 8, 2021