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Clinical Trials/NCT05914883
NCT05914883
Active, not recruiting
Not Applicable

The NORwegian Atrial Fibrillation Self-SCREENing

Oslo University Hospital1 site in 1 country50,000 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Oslo University Hospital
Enrollment
50000
Locations
1
Primary Endpoint
Stroke
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

Atrial fibrillation (AF) is common, increases the risk of mortality, stroke and heart failure, and portending significant burden to patients, societal health and health economy. One of three AF cases are undiagnosed. Several methods for detection of AF exist, but most of them have major limitations and are associated with resource-demanding diagnostic workup in the speciality health care services.

Detailed Description

This randomized clinical trial will evaluate whether self-screening for AF with the ECG247 patch monitor will reduce AF-related morbidity.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 31, 2029
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sigrun Halvorsen

Professor

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥65 years and minimum one other risk factor for stroke according to the CHA2DS2-VASc risk score: Age ≥75 years, Diabetes, Heart failure, Hypertension, Previous stroke/TIA and/or Vascular disease
  • Informed consent for participation

Exclusion Criteria

  • History of AF (self-reported)
  • Use of anticoagulation therapy
  • Pacemaker/CRT device
  • No smart phone

Outcomes

Primary Outcomes

Stroke

Time Frame: 5 years

percent per year

Study Sites (1)

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