Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Assessment by a Critical Event Committee Assessment of Serious Advers Events Cardiovascular Diseases Complications of Antiarrhythmic Drugs or Invasive Procedures Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Thromboembolic and Bleeding Complications Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Staedt. Klinikum, Department of Cardiology

Brandenburg, 14770, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Sponsors and collaborators

Lead sponsor

Atrial Fibrillation Network

Other

Registry information

Official study 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

Acronym: AFNET A7

Important dates

Study start: 2004
Primary completion: 2012
Study completion: 2012
First posted: Sep 5, 2012
Registry last updated: Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed