Atrial FibrillationAFGenLTNCT02518984
Atrial Fibrillation General Registry
An observational study of Atrial Fibrillation, run by European Society of Cardiology at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 19,754 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out patients with AF and patients with acute pre-existing or new onset AF
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial Fibrillation General Long Term Registry
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
vital status
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startOct 2013
- Primary completionAug 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,754 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- European Society of Cardiology
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gregory Lip, MD, Study chair, European Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518984
- Sponsor's protocol ID
- AFGen Long Term
- Acronym
- AFGenLT
- Status last verified
- May 2020
- First submitted
- 16 Apr 2015
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation General Long Term Registry
- ClinicalTrials.gov ID
- NCT02518984
- Acronym / sponsor ID
- AFGenLT / AFGen Long Term
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,754 participants (actual)
- Lead sponsor
- European Society of CardiologyResearch network
- Study start
- Oct 2013 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out patients with AF and patients with acute pre-existing or new onset AF
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vital status
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Lip, MD study chair
European Society of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by European Society of Cardiology at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital status (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.