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The NORwegian Atrial Fibrillation Self-SCREENing

The NORwegian Atrial Fibrillation Self-SCREENing

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914883
Acronym
NORSCREEN
Enrollment
50000
Registered
2023-06-22
Start date
2023-09-01
Completion date
2029-12-31
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DIAGNOSTIC_TESTLong-term continuous ECG monitoring

Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

Sponsors

Sorlandet Hospital HF
CollaboratorOTHER_GOV
Haukeland University Hospital
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Participants will be randomized to screening with continuous ECG screening for 3-7 days, or control/standard of care

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke5 yearspercent per year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026