Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate

Study Overview
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Brief Summary
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To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke

Official Title
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Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease Exclusion Criteria: Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial Fibrillation-potential Patients<br>individuals 65 years of age or older with moderate-to-high risk of stroke | Other: Non-interventional<br>* Non-interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects screened with AF identified at Index Visit |  | Up to 4 weeks | 
| number of subjects screened with AF not identified at Index Visit | number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period | Up to 4 weeks from Index Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with ECG-confirmed AF detected by the Omron BP device | number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period | Day 1 to Day 14 | 
| number of subjects with ECG-confirmed AF detected by MB or HCG-801 | number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period | Day 14 to Day 28 | 
| number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy |  | 24 week follow up period | 
| number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period |  | At week 24 | 
| number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy |  | Day 1 to Day 28 | 
| number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up |  | At week 24 | 
| number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period |  | Index Visit up to week 24 | 
| number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period |  | Day 1 up to week 24 | 
| number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period |  | Index Visit up to week 24 | 
| number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period |  | Day 1 up to week 24 |