An observational study in Atrial Fibrillation (AF), sponsored by Kotyora Family Medicine Health Management and Education Association. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Kotyora Family Medicine Health Management and Education Association · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Kotyora Family Medicine Health Management and Education Association is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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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
Exclusion Criteria:
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.
Diagnostic Test: Monthly 12-lead ECG
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
Incident AF detection rate
Proportion of participants with new AF confirmed on ASM-acquired 12-lead ECG during 12-month follow-up.
Time frame: Baseline through Month 12
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
Plan to share: No
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Kotyora Family Medicine Health Management and Education Association