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Search / Trial NCT03085576

NATional TUnisian REgistry of Atrial Fibrillation

Launched by DACIMA CONSULTING · Mar 14, 2017

Trial Information

Current as of April 30, 2025

Completed

Keywords

Atrial Fibrillation Anticoagulation Stroke Vitamin K Antagonist Cardioversion Inr (International Normalized Ratio)

ClinConnect Summary

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), ...

Gender

ALL

Eligibility criteria

  • 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

About Dacima Consulting

Dacima Consulting is a leading clinical trial sponsor specializing in innovative solutions for the pharmaceutical and biotechnology industries. With a commitment to advancing healthcare, Dacima leverages cutting-edge technology and a team of experienced professionals to design, manage, and execute clinical trials efficiently and effectively. Their comprehensive services encompass protocol development, regulatory support, data management, and statistical analysis, ensuring high-quality results that facilitate the drug development process. Dacima Consulting is dedicated to enhancing patient outcomes through rigorous research, strategic collaboration, and a patient-centered approach.

Locations

Tunis, , Tunisia

Patients applied

0 patients applied

Trial Officials

Faouzi Addad, Professor

Study Chair

Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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