Prospective Registration and Assessment of Serious Adverse Events Within the AFNET (AFNET A7)
|ClinicalTrials.gov Identifier: NCT01678456|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : August 20, 2013
|Condition or disease|
|Atrial Fibrillation Assessment of Serious Advers Events Thromboembolic and Bleeding Complications Complications of Antiarrhythmic Drugs or Invasive Procedures Assessment 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.
|Study Type :||Observational|
|Actual Enrollment :||13000 participants|
|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|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678456
|Staedt. Klinikum, Department of Cardiology|
|Brandenburg, Germany, 14770|
|Principal Investigator:||Michael Oeff, Professor||SAE-Zentrum Brandenburg/Havel Germany|