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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Diagnostic Test: AF screening||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Continuous ECG monitoring for minimum 3 days
Diagnostic Test: AF screening
Continous ECG monitoring for minimum 3 days
- Prevalence of AF [ Time Frame: During procedure ]AF during procedure
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
|Contact: Jarle Jortveit, PhDfirstname.lastname@example.org|
|Arendal, Norway, 4809|
|Contact: Jarle Jortveit, PhD +4799450714 email@example.com|
|Principal Investigator:||Jarle Jortveit, PhD||Sorlandet Hospital Arendal|