NATional TUnisian REgistry of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03085576
• Lead Sponsor: Dacima Consulting

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Primary Completion: 2018-05-30
• Study Completion: 2018-07-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 910

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire; 🇹🇳 Tunis, Tunisia