Atrial Fibrillation (AF)PRO-AF 52NCT07438054
PRO-AF 52: Monthly Primary-Care 12-Lead ECG Screening for Incident Atrial Fibrillation in Adults Aged ≥65 Years
An observational study of Atrial Fibrillation (AF), run by Kotyora Family Medicine Health Management and Education Association at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-arm study will evaluate the feasibility and yield of monthly, in-clinic 12-lead electrocardiogram (ECG) screening performed at affiliated Family Health Centers (Aile Sağlığı Merkezleri; ASMs) in Ordu, Türkiye, among community-dwelling adults aged ≥65 years without a prior diagnosis of atrial… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Monthly 12-lead ECG
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- No healthy volunteers
- Older adult
Study population: Participants aged ≥65 years registered at participating ASMs will undergo monthly standard resting 12-lead ECGs captured on site by trained primary-care staff. All ECGs will be centrally reviewed and reported by cardiologists from the tertiary Cardiology Department. ECG is the only screening/diagnostic tool in the protocol; no wearable/photoplethysmography (PPG) devices or ambulatory patches are used. Participants with newly detected AF will be referred to the tertiary Cardiology Department for guideline-directed care. Decisions regarding OAC initiation, dosing, drug choice, bleeding risk mitigation, and follow-up are made by cardiology as part of routine clinical practice. Participants with sinus rhythm on ASM ECG but palpitations or related symptoms will also be evaluated by cardiology; any additional tests (e.g., Holter monitoring) are outside the study interventions and performed as usual care. At each monthly visit, study staff will capture symptoms, vitals, medications, adverse e
Who may be able to join
- Age ≥65 years.
- Registered at a participating Family Health Center (ASM) in Ordu, Türkiye, with expected availability for 12 months of follow-up.
- Able to provide written informed consent
Who cannot join
- Prior diagnosis of atrial fibrillation or atrial flutter.
- Long-term therapeutic anticoagulation for any indication at baseline.
- Residence in long-term care, hospice, or palliative status.
- Enrollment in another interventional study that conflicts with the protocol.
- Planning to relocate or otherwise unable to attend monthly visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University Faculty of Medicine, Department of Cardiology
Ordu, Ordu, 52200
About this study
Official title: A Prospective, Single-Group, Primary-Care-Based 12-Lead ECG Screening Program With 12-Month Follow-up for Incident Atrial Fibrillation and Guideline-Directed Oral Anticoagulation in Ordu, Türkiye (PRO-AF 52)
This prospective, single-arm study will evaluate the feasibility and yield of monthly, in-clinic 12-lead electrocardiogram (ECG) screening performed at affiliated Family Health Centers (Aile Sağlığı Merkezleri; ASMs) in Ordu, Türkiye, among community-dwelling adults aged ≥65 years without a prior diagnosis of atrial fibrillation (AF). Each participant will be followed for 12 months (12 visits). New AF will be confirmed on ASM-acquired 12-lead ECG and managed by the tertiary Cardiology Department according to contemporary guidelines, including initiation of oral anticoagulation (OAC) when indicated. Outcomes include incident AF detection, OAC initiation and adherence, and ischemic/hemorrhagic clinical events.
Read the detailed description
Participants aged ≥65 years registered at participating ASMs will undergo monthly standard resting 12-lead ECGs captured on site by trained primary-care staff. All ECGs will be centrally reviewed and reported by cardiologists from the tertiary Cardiology Department. ECG is the only screening/diagnostic tool in the protocol; no wearable/photoplethysmography (PPG) devices or ambulatory patches are used. Participants with newly detected AF will be referred to the tertiary Cardiology Department for guideline-directed care. Decisions regarding OAC initiation, dosing, drug choice, bleeding risk mitigation, and follow-up are made by cardiology as part of routine clinical practice. Participants with sinus rhythm on ASM ECG but palpitations or related symptoms will also be evaluated by cardiology; any additional tests (e.g., Holter monitoring) are outside the study interventions and performed as usual care. At each monthly visit, study staff will capture symptoms, vitals, medications, adverse events, and an ECG. Endpoint events will be source-verified (hospital records, imaging, discharge summaries) and adjudicated by a blinded outcomes committee. Visit windows are ±7 days.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Monthly 12-lead ECG
- Keywords
- ECG screening, primary care, older adults, oral anticoagulation, adherence, stroke, bleeding
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly 12-lead ECGDiagnostic test
Standard resting 12-lead ECG performed at each monthly visit (12 visits over 12 months), centrally interpreted by cardiologists. No wearable/PPG devices or ambulatory patches are used in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Single Group: Monthly 12-lead ECG screening + guideline-directed management | All enrolled participants receive monthly 12-lead ECG screening at ASMs for 12 months. Newly detected AF is managed by the tertiary Cardiology Department per routine care, including consideration of OAC when indicated. Receives: Diagnostic Test: Monthly 12-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident AF detection rate
Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.
Measured: Baseline through Month 12
Secondary outcomes (6)
Time to OAC initiation among incident AF
Measured: AF diagnosis to OAC start within 90 days
OAC adherence (MPR ≥80%)
Measured: Months 1-12 after OAC start
Ischemic events (ischemic stroke, TIA, systemic embolism)
Measured: Baseline to Month 12
Hemorrhagic events (ISTH major bleeding; clinically relevant non-major bleeding)
Measured: Baseline to Month 12
All-cause hospitalization
Measured: Baseline to Month 12
Net clinical outcome (ischemic stroke/TIA/systemic embolism, ISTH major bleeding, all-cause death)
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kotyora Family Medicine Health Management and Education Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Seçkin Dereli, MD, Assoc. Prof., Study chair, Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438054
- Sponsor's protocol ID
- KAHSED-003
- Other IDs
- KAHSED-003, KAHSED-003
- Acronym
- PRO-AF 52
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Group, Primary-Care-Based 12-Lead ECG Screening Program With 12-Month Follow-up for Incident Atrial Fibrillation and Guideline-Directed Oral Anticoagulation in Ordu, Türkiye (PRO-AF 52)
- ClinicalTrials.gov ID
- NCT07438054
- Acronym / sponsor ID
- PRO-AF 52 / KAHSED-003
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- ECG screening, primary care, older adults, oral anticoagulation, adherence, stroke, bleeding
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kotyora Family Medicine Health Management and Education AssociationResearch network
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
This prospective, single-arm study will evaluate the feasibility and yield of monthly, in-clinic 12-lead electrocardiogram (ECG) screening performed at affiliated Family Health Centers (Aile Sağlığı Merkezleri; ASMs) in Ordu, Türkiye, among community-dwelling adults aged ≥65 years without a prior diagnosis of atrial fibrillation (AF). Each participant will be followed for 12 months (12 visits). New AF will be confirmed on ASM-acquired 12-lead ECG and managed by the tertiary Cardiology Department according to contemporary guidelines, including initiation of oral anticoagulation (OAC) when indicated. Outcomes include incident AF detection, OAC initiation and adherence, and ischemic/hemorrhagic clinical events.
Detailed description
Participants aged ≥65 years registered at participating ASMs will undergo monthly standard resting 12-lead ECGs captured on site by trained primary-care staff. All ECGs will be centrally reviewed and reported by cardiologists from the tertiary Cardiology Department. ECG is the only screening/diagnostic tool in the protocol; no wearable/photoplethysmography (PPG) devices or ambulatory patches are used. Participants with newly detected AF will be referred to the tertiary Cardiology Department for guideline-directed care. Decisions regarding OAC initiation, dosing, drug choice, bleeding risk mitigation, and follow-up are made by cardiology as part of routine clinical practice. Participants with sinus rhythm on ASM ECG but palpitations or related symptoms will also be evaluated by cardiology; any additional tests (e.g., Holter monitoring) are outside the study interventions and performed as usual care. At each monthly visit, study staff will capture symptoms, vitals, medications, adverse events, and an ECG. Endpoint events will be source-verified (hospital records, imaging, discharge summaries) and adjudicated by a blinded outcomes committee. Visit windows are ±7 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group: Monthly 12-lead ECG screening + guideline-directed management | – | Diagnostic Test: Monthly 12-lead ECGAll enrolled participants receive monthly 12-lead ECG screening at ASMs for 12 months. Newly detected AF is managed by the tertiary Cardiology Department per routine care, including consideration of OAC when indicated. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants aged ≥65 years registered at participating ASMs will undergo monthly standard resting 12-lead ECGs captured on site by trained primary-care staff. All ECGs will be centrally reviewed and reported by cardiologists from the tertiary Cardiology Department. ECG is the only screening/diagnostic tool in the protocol; no wearable/photoplethysmography (PPG) devices or ambulatory patches are used. Participants with newly detected AF will be referred to the tertiary Cardiology Department for guideline-directed care. Decisions regarding OAC initiation, dosing, drug choice, bleeding risk mitigation, and follow-up are made by cardiology as part of routine clinical practice. Participants with sinus rhythm on ASM ECG but palpitations or related symptoms will also be evaluated by cardiology; any additional tests (e.g., Holter monitoring) are outside the study interventions and performed as usual care. At each monthly visit, study staff will capture symptoms, vitals, medications, adverse e
Key inclusion criteria (3 listed)
- Age ≥65 years.
- Registered at a participating Family Health Center (ASM) in Ordu, Türkiye, with expected availability for 12 months of follow-up.
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Prior diagnosis of atrial fibrillation or atrial flutter.
- Long-term therapeutic anticoagulation for any indication at baseline.
- Residence in long-term care, hospice, or palliative status.
- Enrollment in another interventional study that conflicts with the protocol.
- Planning to relocate or otherwise unable to attend monthly visits.
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 |
|---|---|---|
| Monthly 12-lead ECGStandard resting 12-lead ECG performed at each monthly visit (12 visits over 12 months), centrally interpreted by cardiologists. No wearable/PPG devices or ambulatory patches are used in the protocol | Diagnostic test | Single Group: Monthly 12-lead ECG screening + guideline-directed management |
Primary outcome
Incident AF detection rate
Time frame: Baseline through Month 12
Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.
6 secondary outcomes
Time to OAC initiation among incident AF
Time frame: AF diagnosis to OAC start within 90 days
OAC adherence (MPR ≥80%)
Time frame: Months 1-12 after OAC start
Ischemic events (ischemic stroke, TIA, systemic embolism)
Time frame: Baseline to Month 12
Hemorrhagic events (ISTH major bleeding; clinically relevant non-major bleeding)
Time frame: Baseline to Month 12
All-cause hospitalization
Time frame: Baseline to Month 12
Net clinical outcome (ischemic stroke/TIA/systemic embolism, ISTH major bleeding, all-cause death)
Time frame: Baseline to Month 12
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Seçkin Dereli, MD, Assoc. Prof. study chair
Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Kotyora Family Medicine Health Management and Education Association at 1 site in Turkey (Türkiye).
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 5 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. 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 Turkey (Türkiye). 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?
Incident AF detection rate (time frame: Baseline through Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.