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Prospective Registration and Assessment of Serious Adverse Events Within the AFNET (AFNET A7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01678456
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
Atrial Fibrillation Network

Brief 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.

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

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.

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Study Type : Observational
Actual Enrollment : 13000 participants
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
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Real-life population Patients with atrial fibrilation documented within the last 12 months before enrollment

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01678456

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Staedt. Klinikum, Department of Cardiology
Brandenburg, Germany, 14770
Sponsors and Collaborators
Atrial Fibrillation Network
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Principal Investigator: Michael Oeff, Professor SAE-Zentrum Brandenburg/Havel Germany
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Responsible Party: Atrial Fibrillation Network Identifier: NCT01678456    
Other Study ID Numbers: AFNET_A7
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: August 2012

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atrial Fibrillation Network:
Atrial Fibrillation
Critical Event Committee
Serious adverse events
Thromboembolic complications
Cardiac and noncardiac complications
Bleeding complications
Acute heart failure
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes