Atrial Fibrillation Clinical Trial
Official title:
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
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.
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.
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