Prospective Registration and Assessment of Serious Adverse Events Within the AFNET (AFNET A7)
Assessment of Serious Advers Events
Thromboembolic and Bleeding Complications
Complications of Antiarrhythmic Drugs or Invasive Procedures
Assessment by a Critical Event Committee
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
|Study Start Date:||February 2004|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678456
|Staedt. Klinikum, Department of Cardiology|
|Brandenburg, Germany, 14770|
|Principal Investigator:||Michael Oeff, Professor||SAE-Zentrum Brandenburg/Havel Germany|