The NORwegian Atrial Fibrillation Self-SCREENing

NCT05914883 | Active Not Recruiting

• 1 other identifier: 477781
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Stroke

  percent per year

  5 years

Study Arms (2)

ECG screening

EXPERIMENTAL

ECG247 is used for continuous screening for 3-7 days

Diagnostic Test: Long-term continuous ECG monitoring

No ECG screening

NO INTERVENTION

Standard of care

Interventions

Long-term continuous ECG monitoring DIAGNOSTIC_TEST

Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor

ECG screening

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sorlandet Hospital HF: collaborator
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

Oslo Unvirsity Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 39248170 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigrun Halvorsen, PhD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)