Atrial FibrillationNORSCREENNCT05914883
The NORwegian Atrial Fibrillation Self-SCREENing
A study testing Long-term continuous ECG monitoring in people with Atrial Fibrillation, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Long-term continuous ECG monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- History of AF (self-reported)
- Use of anticoagulation therapy
- Pacemaker/CRT device
- No smart phone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This randomized clinical trial will evaluate whether self-screening for AF with the ECG247 patch monitor will reduce AF-related morbidity.
- Conditions
- Atrial Fibrillation
- Being tested
- Long-term continuous ECG monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term continuous ECG monitoringDiagnostic test
Long-term continuous ECG monitoring with ECG247 Smart Heart Sensor
| Study group | Role | What they receive |
|---|---|---|
| ECG screening | Experimental | ECG247 is used for continuous screening for 3-7 days Receives: Diagnostic Test: Long-term continuous ECG monitoring |
| No ECG screening | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
percent per year
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2023
- Primary completionDec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to screening with continuous ECG screening for 3-7 days, or control/standard of care
- Masking
- None (open label)
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Principal investigator, Sigrun Halvorsen, Oslo University Hospital
- Investigators
- Sigrun Halvorsen, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914883
- Sponsor's protocol ID
- 477781
- Acronym
- NORSCREEN
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boskovic M, Haraldsen MB, Berge T, Grenne BL, Skretteberg PT, Engdahl J, Lochen ML, Schuster P, Grimsmo J, Atar D, Anfinsen OG, Pripp AH, Jortveit J, Halvorsen S. Digital recruitment and prevalence of screen-detected atrial fibrillation in nationwide patch-based ECG screening: the NORSCREEN randomized clinical trial. Europace. 2026 Aug 4;28(8):euag140. doi: 10.1093/europace/euag140.
PubMed 42669049Jortveit J, Boskovic M, Haraldsen MB, Berge T, Grenne BL, Munkhaugen J, Halvorsen S. Cardiac-related symptoms in individuals aged >/=65 years without diagnosed cardiac disease: insights from the NORSCREEN trial. Eur Heart J Open. 2026 Feb 20;6(2):oeag032. doi: 10.1093/ehjopen/oeag032. eCollection 2026 Mar.
PubMed 41835810Boskovic 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.
PubMed 39248170
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NORwegian Atrial Fibrillation Self-SCREENing
- ClinicalTrials.gov ID
- NCT05914883
- Acronym / sponsor ID
- NORSCREEN / 477781
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to screening with continuous ECG screening for 3-7 days, or control/standard of care
| Arm | Type | Receives |
|---|---|---|
| ECG screening | Experimental | Diagnostic Test: Long-term continuous ECG monitoringECG247 is used for continuous screening for 3-7 days |
| No ECG screening | No intervention | –Standard of care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- History of AF (self-reported)
- Use of anticoagulation therapy
- Pacemaker/CRT device
- No smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term continuous ECG monitoringLong-term continuous ECG monitoring with ECG247 Smart Heart Sensor | Diagnostic test | ECG screening |
Primary outcome
Stroke
Time frame: 5 years
percent per year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 42669049Boskovic M, Haraldsen MB, Berge T, Grenne BL, Skretteberg PT, Engdahl J, Lochen ML, Schuster P, Grimsmo J, Atar D, Anfinsen OG, Pripp AH, Jortveit J, Halvorsen S. Digital recruitment and prevalence of screen-detected atrial fibrillation in nationwide patch-based ECG screening: the NORSCREEN randomized clinical trial. Europace. 2026 Aug 4;28(8):euag140. doi: 10.1093/europace/euag140.
- Derived from this study: PubMed 41835810Jortveit J, Boskovic M, Haraldsen MB, Berge T, Grenne BL, Munkhaugen J, Halvorsen S. Cardiac-related symptoms in individuals aged >/=65 years without diagnosed cardiac disease: insights from the NORSCREEN trial. Eur Heart J Open. 2026 Feb 20;6(2):oeag032. doi: 10.1093/ehjopen/oeag032. eCollection 2026 Mar.
- Derived from this study: PubMed 39248170Boskovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigrun Halvorsen, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term continuous ECG monitoring in people with Atrial Fibrillation, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.