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Atrial Fibrillation General Registry (AFGenLT)

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ClinicalTrials.gov Identifier: NCT02518984
Recruitment Status : Recruiting
First Posted : August 10, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
European Society of Cardiology

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.

Condition or disease
Atrial Fibrillation

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Atrial Fibrillation General Long Term Registry
Study Start Date : October 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. vital status [ Time Frame: Baseline ]

Other Outcome Measures:
  1. vital status [ Time Frame: one year follow-up ]
  2. vital status [ Time Frame: two year follow-up ]
  3. vital status [ Time Frame: three year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out patients with AF and patients with acute pre-existing or new onset AF
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518984


Contacts
Contact: Thierry Ferreira, MSc 33 (0)4 89 87 20 44 tferreira@escardio.org
Contact: Stéphan Martin, PhD 33 (0)4 89 87 20 44 smartin@escardio.org

Locations
France
European Society of Cardiology Recruiting
Biot, France, 06903
Contact: Thierry Ferreira, MSc    33 489872044 ext 2044    tferreira@escardio.org   
Sponsors and Collaborators
European Society of Cardiology
Investigators
Study Chair: Gregory Lip, MD European Society of Cardiology

Responsible Party: European Society of Cardiology
ClinicalTrials.gov Identifier: NCT02518984     History of Changes
Other Study ID Numbers: AFGen Long Term
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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