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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT01678456
First received: September 14, 2005
Last updated: August 19, 2013
Last verified: August 2012
  Purpose

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
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 Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

Enrollment: 13000
Study Start Date: February 2004
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678456

Locations
Germany
Staedt. Klinikum, Department of Cardiology
Brandenburg, Germany, 14770
Sponsors and Collaborators
German Atrial Fibrillation Network
Investigators
Principal Investigator: Michael Oeff, Professor SAE-Zentrum Brandenburg/Havel Germany
  More Information

No publications provided

Responsible Party: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT01678456     History of Changes
Other Study ID Numbers: AFNET_A7
Study First Received: September 14, 2005
Last Updated: August 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:
Atrial Fibrillation
Critical Event Committee
Serious adverse events
Thromboembolic complications
Cardiac and noncardiac complications
Bleeding complications
Acute heart failure
Syncope
Resuscitation

Additional relevant MeSH terms:
Atrial Fibrillation
Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014