NATional TUnisian REgistry of Atrial Fibrillation "NATURE-AF"

Active, not recruiting

Phase N/A Results N/A

Update History

7 Jul '17
The Summary of Purpose was updated.
New
A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
Old
A non-interventional, national longitudinal study of atrial fibrillation performed with 186 cardiologists.
The description was updated.
New
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.
Old
The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 186 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.
The eligibility criteria were updated.
New
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
Old
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
A location was updated in Tunis.
New
The overall status was removed for STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire.