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The South-Norway Atrial Fibrillation Screening Study (AFstudien)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
AF screening
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sorlandet Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Examination

Arm Description

Continuous ECG monitoring for minimum 3 days

Outcomes

Primary Outcome Measures

Prevalence of AF
AF during procedure

Secondary Outcome Measures

Full Information

First Posted
December 26, 2020
Last Updated
December 2, 2022
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT04700865
Brief Title
The South-Norway Atrial Fibrillation Screening Study
Acronym
AFstudien
Official Title
The South-Norway Atrial Fibrillation Screening Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Examination
Arm Type
Other
Arm Description
Continuous ECG monitoring for minimum 3 days
Intervention Type
Diagnostic Test
Intervention Name(s)
AF screening
Intervention Description
Continous ECG monitoring for minimum 3 days
Primary Outcome Measure Information:
Title
Prevalence of AF
Description
AF during procedure
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarle Jortveit, PhD
Organizational Affiliation
Sorlandet Hospital Arendal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
ZIP/Postal Code
4809
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35186075
Citation
Jortveit J, Fensli R. Remote ECG Monitoring by ECG247 Smart Heart Sensor. Int J Telemed Appl. 2022 Feb 11;2022:6812889. doi: 10.1155/2022/6812889. eCollection 2022.
Results Reference
derived
PubMed Identifier
34765102
Citation
Sandberg EL, Grenne BL, Berge T, Grimsmo J, Atar D, Halvorsen S, Fensli R, Jortveit J. Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology. J Healthc Eng. 2021 Nov 2;2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.
Results Reference
derived
Links:
URL
http://www.afstudien.no
Description
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The South-Norway Atrial Fibrillation Screening Study

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