Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

Atrial Fibrillation Clinical Trial

— AFNET A7  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678456
• Other study ID #: AFNET_A7
• Status: Completed
• Start date: February 2004
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Atrial Fibrillation Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13000
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Atrial fibrillation documented by ECG not older then one year

• Age > 18 years

• Informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Assessment by a Critical Event Committee
• Assessment of Serious Advers Events
• Atrial Fibrillation
• Complications of Antiarrhythmic Drugs or Invasive Procedures
• Hemorrhage
• Thromboembolic and Bleeding Complications

Locations

Country	Name	City	State
Germany	Staedt. Klinikum, Department of Cardiology	Brandenburg

Sponsors (1)

Lead Sponsor	Collaborator
Atrial Fibrillation Network

Country where clinical trial is conducted

Germany,