Clinical trial NCT02518984: Atrial Fibrillation General Registry
Official title: Atrial Fibrillation General Long Term Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: European Society of Cardiology
Sponsor class: NETWORK
First posted: 2015-08-10
Enrollment: 19754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out patients with AF and patients with acute pre-existing or new onset AF

Brief summary: Given the advances in Atrial Fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was needed.

Detailed description: Given the advances in Atrial Fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was needed.

New guidelines on the management of AF have recently been published by the ESC, but it remains unclear how often clinicians adhere to them. Since the last Euro Heart survey, a change in management strategy has necessitated an update on prevalent management practices in AF. This is influenced by clinical availability of catheter ablation as a routine procedure and new antiarrhythmic drugs, and also by developments in stroke thromboprophylaxis and medical therapy options. Under the EURObservational Research Programme (EORP), an AF ablation sentinel pilot registry was launched in 2010.

A survey of AF management under the EORP programme will enable a timely assessment of the uptake of the new ESC guidelines, allow monitoring of implementation and uptake of catheter ablation, new antithrombotic drugs and new antiarrhythmic agents, and will inform about outcomes related to guideline-adherent management of AF.

Eligibility criteria: Inclusion Criteria:

* Patients will be officially enrolled in the study only if ECG diagnosis of AF has been made.
* The qualifying episode of AF should have occurred within one year before the date of baseline.
* AF is the primary or secondary diagnosis, i.e. the current admission / visit may be due to other reasons.
* Patients need not be in AF at the time of enrolment.
* Signed Patient Inform Consent if applicable.

Exclusion Criteria:

* No ECG/Holter with AF recorded.
* Only atrial flutter recorded.
* The qualifying episode of AF occurred more than one year before the date of baseline.
* Age \<18 years.
* Patients are already included in the ESC Atrial Fibrillation Long-Term registry if your centre was enrolled in the Pilot phase.
* Patients who are currently or are planned to be taking part in a cardiac clinical trial.

Primary outcomes:
measure: vital status
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: vital status
timeFrame: one year follow-up
measure: vital status
timeFrame: two year follow-up
measure: vital status
timeFrame: three year follow-up
Locations:
city: Biot
country: France
facility: European Society of Cardiology
Study officials:
affiliation: European Society of Cardiology
name: Gregory Lip, MD
role: STUDY_CHAIR
References: