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Atrial Fibrillation (AF)PAFS-TromsøNCT07343895

Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study

A study testing Long term heart rythm monitoring by ECG247 in people with Atrial Fibrillation (AF) and Stroke, run by University Hospital of North Norway at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim is to investigate whether screening with long-term ECG monitoring in individuals with elevated NT-proBNP leads to a lower incidence of ischeamic stroke and death from vascular causes. The project is a sub-study within the 8th wave of the population based Tromsø Study. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation (AF), Stroke, NT-pro-BNP
What is being tested?
Long term heart rythm monitoring by ECG247
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
2 sitesNorway
Study dates
24 Oct 2025to 1 Mar 2035
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥40 years
  • NT-proBNP> median level
  • Informed consent for participation

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Agnethe Eltoft, MD, PhD contact

+4797193417

agnethe.eltoft@unn.no

Emelia Gjesvik contact

emelia.e.gjesvik@uit.no

Norway2 sites, 2 recruiting

  • Uit The Arctic University of Norway

    Tromsø, 1902

    Agnethe Eltoft, MD, PhD, 004797193417, agnethe.eltoft@uit.no

    Recruiting

  • University Hospital of North Norway Health Trust

    Tromsø

    Agnethe Eltoft, MD, PhD, agnethe.eltoft@unn.no

    Recruiting

Other trials in Norway

About this study

Official title: Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study

The aim is to investigate whether screening with long-term ECG monitoring in individuals with elevated NT-proBNP leads to a lower incidence of ischeamic stroke and death from vascular causes. The project is a sub-study within the 8th wave of the population based Tromsø Study. Information on previous diseases, medication use, and risk factors is collected through questionnaires, blood samples, and measurements of height, weight, blood pressure, and ECG.

A total of 4,000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized to either long-term heart rhythm monitoring (7 days) or a control group without long-term ECG monitoring (2,000 in each group). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.

The intervention group and the control group will be compared with regards to incident stroke and death within a 6-year follow-up period. Information on endpoints and anticoagulation use will be obtained through linkage to national registries.

Read the detailed description

This project has the potential for providing new knowledge related to the benefit of a stepwise screening approach for AF according to NT-proBNP level, utilizing a novel patch monitor with continuous ECG monitoring and automatic artificial intelligence based (AI) ECG analysis. The present project is planned as a sub-study of the epidemiological population-based Tromsø Study. In a randomized controlled clinical trial, we plan to test the primary hypothesis that in individuals with elevated NT-ProBNP who are diagnosed with AF through long-term ECG monitoring, anticoagulation treatment according to international guidelines will reduce the incidence of incident ischeamic stroke and cardiovascular death in the screening group compared to individuals who do not undergo screening (control group). The study will be performed within a well-defined cohort with extensive available longitudinal and cross-sectional information on risk factors and co-existing conditions. This setup facilitates addressing several knowledge gaps concerning risk stratification including associations between AF and echocardiographic parameters, cognitive impairment, structural changes on brain MRI, and HRQoL.

Being tested
Long term heart rythm monitoring by ECG247
Keywords
ECG247, Atrial Fibrillation, Stroke, NT-Pro-BNP, Cognitive decline, Life Quality, Heart Failure
Medical subject headings
Atrial Fibrillation, Stroke, Heart Failure, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long term heart rythm monitoring by ECG247Diagnostic test

    The AF screening device will be sent by post from the study centre to participants in the intervention group at inclusion, free-of-charge. User guides and a "help-desk" located at the University Hospital of North Norway will be available for phone/video assistance. Continuous ECG monitoring using the Norwegian produced ECG247 sensor will be performed for 5-7 days. Single lead ECG data is sent to a cloudbased server intermittently. The system stores information of ECG quality and is evaluated by trained algorithms which classify arrhythmias based on current criteria. All ECG recordings will be reviewed by a group of trained and experienced study nurses and physicians. In the event of clinically relevant arrhythmias, participants will be contacted as soon as possible and receive advice on follow-up with their general practitioner. Anticoagulation therapy and other treatments will be recommended if indicated according to current guidelines.

Study groups in NCT07343895
Study groupRoleWhat they receive
Intervention armExperimentalA total of 2000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized long-term heart rhythm monitoring using ECG247 (5-7 days). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.
Receives: Diagnostic Test: Long term heart rythm monitoring by ECG247
ControlNo interventionThe control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with the composite outcome of ischemic stroke or cardiovascular death

    Composite outcome of ischemic stroke and cardiovascular death

    Measured: Within 6 years of screening

  2. Number of participants with ischemic stroke

    Ischemic stroke outcome

    Measured: Within 6 years of screening

  3. Number of participants with intracerebral hemorrhage

    Intracerebral hemorrhage outcome

    Measured: Within 6 years of screening

  4. Number of participants with cardiovascular death

    Cardiovascular death outcome

    Measured: Within 6 years of screening

Secondary outcomes (14)

  1. Number of participants with atrial fibrillation

    Atrial fibrillation prevalence

    Measured: Within 14 days of screening

  2. Duration of atrial fibrillation in hours

    Atrial fibrillation burden

    Measured: Within 14 days of screening

  3. Left atrial volume index

    Echocardiographic measure

    Measured: Within 1 year of screening

  4. Left atrial reservoir strain

    Echocardiographic measures

    Measured: Within 1 year of screening

  5. Score on the 12-word immediate recall test

    Cognitive test performance outcome

    Measured: Within 6 years of screening

  6. Score on the Mini-Mental State Examination (MMS-E)

    Cognitive test performance outcome

    Measured: Within 6 years of screening

  7. Score on the digit symbol coding test

    Cognitive test performance outcome

    Measured: Within 6 years of screening

  8. Score on the HRQoL EuroQol-5 Dimension (EQ5D)

    Health related quality of life (HRQoL) outcome

    Measured: Within one year of screening

  9. Score on the Whiteley Index

    Health anxiety outcome

    Measured: Within one year of screening

  10. Global brain volume

    Brain MRI measures

    Measured: Within 2.5 years of screening

  11. Segmental brain volume

    Brain MRI measures

    Measured: Within 2.5 years of screening

  12. Volume of white matter lesions

    Brain MRI measures

    Measured: Within 2.5 years of screening

  13. Number of clinical and subclinical infarcts

    Brain MRI measures

    Measured: Within 2.5 years of screening

  14. Number og micro-hemorrhages

    Brain MRI measures

    Measured: Within 2.5 years of screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start24 Oct 2025
  3. Primary completion1 Mar 2032 (estimated)
  4. Study completion1 Mar 2035 (estimated)

Resources

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
In the planned open label randomized screening trial trial we plan to include 4000 individuals fra the 8th wave of the population based Tromsø Study with NT-proBNP above median without previous known AF or ongoing anticoagulant treatment. Participants will be randomized 1:1 to continuous ECG monitoring using the Norwegian produced ECG247 sensor. og to the control group without any monitoring of heart rythm.
Masking
None (open label)
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343895
Sponsor's protocol ID
2025/856478 (REK)
Other IDs
2025
Acronym
PAFS-Tromsø
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
15 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Long term heart rythm monitoring by ECG247 in people with Atrial Fibrillation (AF) and Stroke, run by University Hospital of North Norway at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Agnethe Eltoft, MD, PhD (+4797193417, agnethe.eltoft@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with the composite outcome of ischemic stroke or cardiovascular death (time frame: Within 6 years of screening). The study lists 4 primary outcomes in all. 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 NCT07343895.

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 15 Jan 2026.

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