A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
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.
Patients with atrial fibrillation
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death||Every 3 months up to 1 year|
|Secondary||Haemorrhagic accidents||Every 3 months up to 1 year|
|Secondary||Measurement of INR (International Normalized Ratio)||Every month for 1 year|
|Secondary||TTR (percent Time in Therapeutic INR Range)||1 year|