NCT01678456

Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

Prospective Registration and Independent Assessment of Incidence, Clinical Relevance and Outcome of Serious Adverse Events (SAE) Registered in the German Competence Network on Atrial Fibrillation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,000 (actual)
• Sponsor: Atrial Fibrillation Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2004-02-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-09-05
• Last updated: 2020-09-22

Locations

1 site across 1 country: Germany