Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

Completed

• Conditions: Atrial Fibrillation; Thromboembolic and Bleeding Complications; Complications of Antiarrhythmic Drugs or Invasive Procedures; Assessment of Serious Advers Events; Assessment by a Critical Event Committee

• Registration Number: NCT01678456
• Lead Sponsor: Atrial Fibrillation Network

Brief Summary

Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.

Detailed Description

Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a significantly enhanced mortality and morbidity due to thromboembolic events, and other cardiac and noncardiac complications. Therefore the "Network of Competence on Atrial Fibrillation (AFNET)" supported by the German Ministry for Education and Research (BMBF) was established in order to collect clinical data on patients (pts) with AF (paroxysmal, persistent, permanent) over a study period of 6 years with an expected sample size of 12,000 pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a Critical Event Committee (CEC).

The CEC-members (experts in cardiology and neurology) defined as SAE any death with or without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism), bleeding complications due to antithrombotic therapy, acute heart failure, syncope, resuscitation; additionally, the complication of interventional strategies for AF-treatment and other AF-independent SAEs.

Over a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are systematically documented, blinded and their relationship to AF will be interpreted in detail by the CEC.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-14
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-05
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13000

Inclusion Criteria

• Atrial fibrillation documented by ECG not older then one year
• Age > 18 years
• Informed consent

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Staedt. Klinikum, Department of Cardiology; 🇩🇪 Brandenburg, Germany