The NORwegian Atrial Fibrillation Self-SCREENing

NCT ID: NCT05914883

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2029-12-31

Brief Summary

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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

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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SCREENING

Blinding Strategy

NONE

Study Groups

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ECG screening

ECG247 is used for continuous screening for 3-7 days

Group Type EXPERIMENTAL

Long-term continuous ECG monitoring

Intervention Type DIAGNOSTIC_TEST

Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

No ECG screening

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Long-term continuous ECG monitoring

Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sigrun Halvorsen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sigrun Halvorsen, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo Unvirsity Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Boskovic M, Jortveit J, Haraldsen MB, Berge T, Engdahl J, Lochen ML, Schuster P, Sandberg EL, Grimsmo J, Atar D, Anfinsen OG, Pripp AH, Grenne BL, Halvorsen S. The NORwegian atrial fibrillation self-SCREENing (NORSCREEN) trial: rationale and design of a randomized controlled trial. Europace. 2024 Oct 3;26(10):euae228. doi: 10.1093/europace/euae228.

Reference Type DERIVED
PMID: 39248170 (View on PubMed)

Other Identifiers

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477781

Identifier Type: -

Identifier Source: org_study_id

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