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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518984
Other study ID # AFGen Long Term
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date December 2019

Study information

Verified date May 2020
Source European Society of Cardiology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19754
Est. completion date December 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France European Society of Cardiology Biot

Sponsors (1)

Lead Sponsor Collaborator
European Society of Cardiology

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other vital status one year follow-up
Other vital status two year follow-up
Other vital status three year follow-up
Primary vital status Baseline
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