Atrial FibrillationAFstudienNCT04700865
The South-Norway Atrial Fibrillation Screening Study
A study testing AF screening in people with Atrial Fibrillation, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF 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?
- AF screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteNorway
- Study dates
- 23 Dec 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor)
- Informed written consent for participation
Who cannot join
- Chronic AF
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF
Read the detailed description
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke. Many AF cases are undiagnosed due to the asymptomatic and intermittent nature of AF (silent AF). Today there is no simple and inexpensive method of detecting silent AF and thus preventing stroke. The ECG247 Sensor is a new Norwegian digital clinical tool for out-of-hospital self-testing of AF. The innovation project has originated from the University of Agder and Sorlandet Hospital. The COVID19 pandemic is realizing more than ever the need for single-use self-testing out-of-hospital diagnostic tools.
The general aim of this open non-randomized study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF in a cohort of 1500 65-year-old individuals with additional risk factors for stroke.
If the study results indicate that easy-to-use continuous AF-screening-devices designed for self-testing can identify people with previously unrecognized AF, this study may contribute to change the approach to screening for AF in the community. Consequently, the study may prevent stroke in the future. By preventing stroke, major personal and socio-economic consequences can be avoided.
- Conditions
- Atrial Fibrillation
- Being tested
- AF screening
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF screeningDiagnostic test
Continous ECG monitoring for minimum 3 days
| Study group | Role | What they receive |
|---|---|---|
| Examination | Other | Continuous ECG monitoring for minimum 3 days Receives: Diagnostic Test: AF screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AF
AF during procedure
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start23 Dec 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jarle Jortveit, PhD, Principal investigator, Sorlandet Hospital Arendal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700865
- Sponsor's protocol ID
- 20/09000-7
- Acronym
- AFstudien
- Status last verified
- Dec 2020
- First submitted
- 26 Dec 2020
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Leangen Grenne B, Jortveit J. Digital recruitment and compliance to treatment recommendations in the Norwegian Atrial Fibrillation self-screening pilot study. Eur Heart J Digit Health. 2024 Apr 9;5(3):371-378. doi: 10.1093/ehjdh/ztae026. eCollection 2024 May.
PubMed 38774377Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Grenne BL, Jortveit J. Screening for Atrial Fibrillation by Digital Health Technology in Older People in Homecare Settings: A Feasibility Trial. Int J Telemed Appl. 2024 Mar 25;2024:4080415. doi: 10.1155/2024/4080415. eCollection 2024.
PubMed 38567031Jortveit J, Boskovic M, Sandberg EL, Vegsundvag J, Halvorsen S. High Diagnostic Accuracy of Long-Term Electrocardiogram Interpretation by General Practitioners. Int J Telemed Appl. 2024 Feb 22;2024:6624344. doi: 10.1155/2024/6624344. eCollection 2024.
PubMed 38425473Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Fensli R, Grenne BL, Jortveit J. Fully digital self-screening for atrial fibrillation with patch electrocardiogram. Europace. 2023 May 19;25(5):euad075. doi: 10.1093/europace/euad075.
PubMed 36945146Jortveit J, Fensli R. Remote ECG Monitoring by ECG247 Smart Heart Sensor. Int J Telemed Appl. 2022 Feb 11;2022:6812889. doi: 10.1155/2022/6812889. eCollection 2022.
PubMed 35186075Sandberg EL, Grenne BL, Berge T, Grimsmo J, Atar D, Halvorsen S, Fensli R, Jortveit J. Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology. J Healthc Eng. 2021 Nov 2;2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.
PubMed 34765102
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The South-Norway Atrial Fibrillation Screening Study
- ClinicalTrials.gov ID
- NCT04700865
- Acronym / sponsor ID
- AFstudien / 20/09000-7
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Jan 2021 (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 the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF
Detailed description
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke. Many AF cases are undiagnosed due to the asymptomatic and intermittent nature of AF (silent AF). Today there is no simple and inexpensive method of detecting silent AF and thus preventing stroke. The ECG247 Sensor is a new Norwegian digital clinical tool for out-of-hospital self-testing of AF. The innovation project has originated from the University of Agder and Sorlandet Hospital. The COVID19 pandemic is realizing more than ever the need for single-use self-testing out-of-hospital diagnostic tools.
The general aim of this open non-randomized study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF in a cohort of 1500 65-year-old individuals with additional risk factors for stroke.
If the study results indicate that easy-to-use continuous AF-screening-devices designed for self-testing can identify people with previously unrecognized AF, this study may contribute to change the approach to screening for AF in the community. Consequently, the study may prevent stroke in the future. By preventing stroke, major personal and socio-economic consequences can be avoided.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Examination | Other | Diagnostic Test: AF screeningContinuous ECG monitoring for minimum 3 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age >65 years
- Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor)
- Informed written consent for participation
Key exclusion criteria (2 listed)
- Chronic AF
- Lack of ability to cooperate
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 |
|---|---|---|
| AF screeningContinous ECG monitoring for minimum 3 days | Diagnostic test | Examination |
Primary outcome
Prevalence of AF
Time frame: During procedure
AF during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 38774377Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Leangen Grenne B, Jortveit J. Digital recruitment and compliance to treatment recommendations in the Norwegian Atrial Fibrillation self-screening pilot study. Eur Heart J Digit Health. 2024 Apr 9;5(3):371-378. doi: 10.1093/ehjdh/ztae026. eCollection 2024 May.
- Derived from this study: PubMed 38567031Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Grenne BL, Jortveit J. Screening for Atrial Fibrillation by Digital Health Technology in Older People in Homecare Settings: A Feasibility Trial. Int J Telemed Appl. 2024 Mar 25;2024:4080415. doi: 10.1155/2024/4080415. eCollection 2024.
- Derived from this study: PubMed 38425473Jortveit J, Boskovic M, Sandberg EL, Vegsundvag J, Halvorsen S. High Diagnostic Accuracy of Long-Term Electrocardiogram Interpretation by General Practitioners. Int J Telemed Appl. 2024 Feb 22;2024:6624344. doi: 10.1155/2024/6624344. eCollection 2024.
- Derived from this study: PubMed 36945146Sandberg EL, Halvorsen S, Berge T, Grimsmo J, Atar D, Fensli R, Grenne BL, Jortveit J. Fully digital self-screening for atrial fibrillation with patch electrocardiogram. Europace. 2023 May 19;25(5):euad075. doi: 10.1093/europace/euad075.
- Derived from this study: PubMed 35186075Jortveit J, Fensli R. Remote ECG Monitoring by ECG247 Smart Heart Sensor. Int J Telemed Appl. 2022 Feb 11;2022:6812889. doi: 10.1155/2022/6812889. eCollection 2022.
- Derived from this study: PubMed 34765102Sandberg EL, Grenne BL, Berge T, Grimsmo J, Atar D, Halvorsen S, Fensli R, Jortveit J. Diagnostic Accuracy and Usability of the ECG247 Smart Heart Sensor Compared to Conventional Holter Technology. J Healthc Eng. 2021 Nov 2;2021:5230947. doi: 10.1155/2021/5230947. eCollection 2021.
- Related InfoLink provided by the sponsor.
- 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.
Jarle Jortveit, PhD principal investigator
Sorlandet Hospital Arendal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF screening in people with Atrial Fibrillation, run by Sorlandet Hospital HF 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of AF (time frame: During procedure). 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 NCT04700865, which also lists 6 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 5 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.