Atrial Fibrillation and Other Dysrhythmias | PatientFLAACNCT02252861
French Database of Left Atrial Appendage Closure
An observational study of Atrial Fibrillation and Other Dysrhythmias | Patient, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Other Dysrhythmias | Patient
- What is being tested?
- Percutaneous Left Atrial Appendage Closure in routine care
- How many people
- 840 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Sep 2018
- How long will I take part?
- 5 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: All patients referred for percutaneous Left Atrial Appendage Closure to one of the French centers involved in this database
Who may be able to join
- Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care
- Signature of an inform consent form for inclusion of data recorded during care in the database
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.
This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.
Read more
This database is strictly observational.
Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
- Being tested
- Percutaneous Left Atrial Appendage Closure in routine care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Left Atrial Appendage Closure in routine careOther
The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Appendage Closure | Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care Receives: Other: Percutaneous Left Atrial Appendage Closure in routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
Measured: 1 year
Secondary outcomes (7)
Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)
Measured: 1 year
Death rate from cardiovascular disease after left atrial appendage closure
Measured: 1 year
Unexplained Death rate after left atrial appendage closure
Measured: 1 year
Adverse events related to the procedure
Measured: 1 year
Cost of the procedure of left atrial appendage closure
Measured: Costs will be assessed for the duration of hospital stay, an expected average of 3 days
Cost of patient follow-up after left atrial appendage closure
Measured: 1 year
Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and Other Dysrhythmias | PatientStudies 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
- 840 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French association for research in cardiology (ARCARD)
- Responsible party
- Principal investigator, Philippe Le Corvoisier, Henri Mondor University Hospital
- Investigators
- Emmanuel Teiger, MD, PhD, Principal investigator, emmanuel.teiger@hmn.aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252861
- Sponsor's protocol ID
- FLAAC
- Acronym
- FLAAC
- Status last verified
- Feb 2021
- First submitted
- 22 Sep 2014
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Spaulding C, Armero S, Champagnac D, Bhugaloo H, Ternacle J, Lellouche N, Audureau E, Le Corvoisier P; French national Left Atrial Appendage Closure registry (FLAAC) investigators. Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry. Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.
PubMed 34051135Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Pasquie JL, Rioufol G, Lepillier A, Elbaz M, Horvilleur J, Brenot P, Pierre B, Le Corvoisier P; French National Left Atrial Appendage Closure Registry (FLAAC) Investigators. Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events. Circ Cardiovasc Interv. 2018 Mar;11(3):e005841. doi: 10.1161/CIRCINTERVENTIONS.117.005841.
PubMed 29540492
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Database of Left Atrial Appendage Closure
- ClinicalTrials.gov ID
- NCT02252861
- Acronym / sponsor ID
- FLAAC / FLAAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Collaborators
- French association for research in cardiology (ARCARD)
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 30 Sep 2014 (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.
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.
This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.
This database is strictly observational.
Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Appendage Closure | – | Other: Percutaneous Left Atrial Appendage Closure in routine carePatients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for percutaneous Left Atrial Appendage Closure to one of the French centers involved in this database
Key inclusion criteria (2 listed)
- Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care
- Signature of an inform consent form for inclusion of data recorded during care in the database
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Left Atrial Appendage Closure in routine careThe inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database. | Other | Left Atrial Appendage Closure |
Primary outcome
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
Time frame: 1 year
7 secondary outcomes
Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)
Time frame: 1 year
Death rate from cardiovascular disease after left atrial appendage closure
Time frame: 1 year
Unexplained Death rate after left atrial appendage closure
Time frame: 1 year
Adverse events related to the procedure
Time frame: 1 year
Cost of the procedure of left atrial appendage closure
Time frame: Costs will be assessed for the duration of hospital stay, an expected average of 3 days
Cost of patient follow-up after left atrial appendage closure
Time frame: 1 year
Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)
Time frame: 1 year
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 9 Feb 2021.
- Derived from this study: PubMed 34051135Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Spaulding C, Armero S, Champagnac D, Bhugaloo H, Ternacle J, Lellouche N, Audureau E, Le Corvoisier P; French national Left Atrial Appendage Closure registry (FLAAC) investigators. Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry. Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.
- Derived from this study: PubMed 29540492Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Pasquie JL, Rioufol G, Lepillier A, Elbaz M, Horvilleur J, Brenot P, Pierre B, Le Corvoisier P; French National Left Atrial Appendage Closure Registry (FLAAC) Investigators. Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events. Circ Cardiovasc Interv. 2018 Mar;11(3):e005841. doi: 10.1161/CIRCINTERVENTIONS.117.005841.
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.
Emmanuel Teiger, MD, PhD principal investigator
emmanuel.teiger@hmn.aphp.fr
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 and Other Dysrhythmias | Patient, run by Henri Mondor University Hospital 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 2 inclusion and 1 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 9 Feb 2021. 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?
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02252861, which also lists 2 linked publications.
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 9 Feb 2021.