Prospective Registration and Assessment of Serious Adverse Events Within the AFNET (AFNET A7)
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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 |
| Estimated Enrollment: | 13000 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2012 |
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 |
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
Contacts and Locations| Contact: Michael Oeff, Professor | + 49 3381 41 15 12 | oeff@klinikum-brandenburg.de |
| Germany | |
| Staedt. Klinikum, Department of Cardiology | Recruiting |
| Brandenburg, Germany, 14770 | |
| Contact: Claudia Sprenger +49 3381 41 15 12 sprenger@klinikum-brandenburg.de | |
| 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 31, 2012 |
| 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 May 19, 2013