The NORwegian Atrial Fibrillation Self-SCREENing (NORSCREEN)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Long-term continuous ECG monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05914883

477781

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50,000 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50,000 participants in 2 patient groups

ECG screening

Experimental group

Description:

ECG247 is used for continuous screening for 3-7 days

Treatment:

Diagnostic Test: Long-term continuous ECG monitoring

No ECG screening

No Intervention group

Description:

Standard of care