NATional TUnisian REgistry of Atrial Fibrillation

Study Overview
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Brief Summary
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A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.

Detailed Description
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The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 91 cardiologists participate in the selection of patients as investigators. The study is a longitudinal non-interventional registry of atrial fibrillation. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.

Official Title
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National Tunisian Registry of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a rhythmic holter (duration of the episode: 30 seconds or more) Recent atrial fibrillation diagnosed for less than a year Regular monitoring every 3 months is ensured Informed, read and signed consent Exclusion Criteria: Estimated life expectancy at less than 12 months Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction, following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary embolism or other acute pulmonary disease, pericarditis, myocarditis, hydro-electrolyte disorder, metabolic disorder) Cardiac surgery ≤ 3 months Atrial flutter isolated without atrial fibrillation Mental disorders Ongoing anticoagulation for reasons other than atrial fibrillation

Ages Eligible for Study
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Minimum Age: 20 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death | Number of patients with ischemic stroke and/or transient ischemic attack, and/or arterial embolization during the follow-up period | Every 3 months up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemorrhagic accidents | All bleeding events (digestive, cerebral, other locations) | Every 3 months up to 1 year | 
| Measurement of INR (International Normalized Ratio) | INR measurement of venous blood sampling | Every month for 1 year | 
| TTR (percent Time in Therapeutic INR Range) | The mean TTR obtained in patients who received anticoagulant therapy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Anticoagulation, Stroke, Vitamin K antagonist, Cardioversion, INR (International Normalized Ratio)