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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 13000

Contacts and Locations

Study Locations

• Germany
  • Brandenburg, Germany, 14770
    • Staedt. Klinikum, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Real-life population Patients with atrial fibrilation documented within the last 12 months before enrollment

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Atrial Fibrillation Network
• Investigators: Principal Investigator: Michael Oeff, Professor, SAE-Zentrum Brandenburg/Havel Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimate): September 5, 2012

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Syncope; Acute heart failure; Resuscitation; Bleeding complications; Thromboembolic complications; Serious adverse events; Critical Event Committee; Cardiac and noncardiac complications
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: AFNET_A7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No