Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

NCT ID: NCT01678456

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2012-12-31

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.

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrial Fibrillation Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Oeff, Professor

Role: PRINCIPAL_INVESTIGATOR

SAE-Zentrum Brandenburg/Havel Germany

Locations

Staedt. Klinikum, Department of Cardiology

Brandenburg, , Germany

Countries

Germany

Other Identifiers

AFNET_A7

Identifier Type: -

Identifier Source: org_study_id