Atrial FibrillationFLAAC3NCT05565209
Left Atrial Appendage Closure Registry of Henri Mondor Hospital
An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SA brief descriptive name used to refer to the intervention(s) studied
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2022to 14 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A description of the population from which the groups or cohorts will be selected
Who may be able to join
- Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)
Who cannot join
- Refusal of the patient to participate in this study
- Minor patient
- Patient not affiliated to the French social security system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.
Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.
Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.
- Conditions
- Atrial Fibrillation
- Being tested
- SA brief descriptive name used to refer to the intervention(s) studied
- Keywords
- Atrial fibrillation, Left atrial appendage closure, stroke, anticoagulation, bleeding
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA brief descriptive name used to refer to the intervention(s) studiedOther
Details that can be made public about the intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of thrombo-embolic events
The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.
Measured: 60months of follow-up after the procedure
Secondary outcomes (19)
Efficacy of the procedure
: At the end of the procedure, the efficiency of the procedure will be described by the percentage of success of the procedure. The successful procedure is defined by a successful implantation of the device in the left atrial appendage without presaging its occlusive character.
One hour after the end of the procedure
Measured: One hour after the end of the procedure
Occlusion of the left atrial appendage
The percentage of left atrial appendage occlusion is defined as the percentage of patients where left atrial appendage is efficiently closed at by transesophageal echography and / or CT scan Time Frame: 3 months
Measured: 3 months
residual peri-device leak
The percentage a patients with 3 months residual peri-device leak will be determined at transesophageal echography and / or CT scan
Measured: 3 months
Percentage of ischemic stroke
Percentage of patients with at least one ischemic stroke during the study
Measured: 1 and 5 years after the procedure
Percentage of transient ischemic attack (TIA)
Percentage of patients presenting at least one systemic embolism during the study
Measured: 1 and 5 years after the procedure
Percentage of systemic embolism
Percentage of patients presenting at least one systemic embolism during the study
Measured: 1 and 5 years after the procedure
Cardiovascular or unexplained death
Percentage of patients who had a cardiovascular or unexplained death during the study
Measured: 1 and 5 years after the procedure
All-cause mortality
percentage of all cause deaths
Measured: 1 and 5 years after the procedure
Comparison of the rate of thromboembolic events to expected values
the observed rate of thromboembolic event will be compared to the expected value, according the individual patients CHA2DS2-VASc scores
Measured: 1 and 5 years after the procedure
Rate of complications related or potentially related to the device or the implantation procedure
: Rate of complications related or potentially related to the device or the implantation procedure
Measured: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion
Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound
Measured: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion
Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound
Measured: 3 months
Percentage of migration of the device
Percentage of patients who presented a migration of the device, objectified by echocardiography and / or CT scan
Measured: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of migration of the device
: Percentage of patients who presented a migration of the device, objectified by the echocardiography and / or CT scan
Measured: 3 months; 1 year; 5 years
Percentage of device thrombosis
Percentage of patients who presented a thrombosis on the device, objectified by transesophageal echography and / or CT scan
Measured: 3 months; 1 year; 5 year
Bleeding (all cause)
Percentage of patients who presented a bleeding
Measured: 1 year; 5 year
Bleedings not-related to the procedure or the device
Percentage of patients who presented a bleeding not-related to the procedure or the device
Measured: 1 year; 5 year
Criteria for Evaluating Associated Antithrombotic Treatments
The antithrombotic treatments will be collected at different follow-up times.
The type and duration of anti-thrombotic treatments will be documented using the combined criteria:
- Percentage of patients on injectable or oral anticoagulants and antiplatelet agents at different follow-up times
- Percentage of patients on injectable or oral anticoagulants at different follow-up times
- The percentage of patients on platelet antiaggregants in single or dual therapy at different follow-up times
Measured: : Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure
Description of the population
Demographic and clinical characteristics of the patients will be collected and described, such as: age, sex, medical and surgical history, cardiovascular pharmacological treatments, comorbidities, indication of left atrial closure, HAS-BLED and CHA2DS2-VASc scores, anatomical features of the left atrial appendage at inclusion.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start24 Sep 2022
- Primary completion14 Sep 2026 (estimated)
- Study completion14 Sep 2026 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565209
- Sponsor's protocol ID
- APHP220614
- Acronym
- FLAAC3
- Status last verified
- Feb 2025
- First submitted
- 15 Sep 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Closure Registry of Henri Mondor Hospital
- ClinicalTrials.gov ID
- NCT05565209
- Acronym / sponsor ID
- FLAAC3 / APHP220614
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Left atrial appendage closure, stroke, anticoagulation, bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 14 Sep 2026 (estimated)
- First posted
- 4 Oct 2022 (actual)
- 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.
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.
Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.
Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A description of the population from which the groups or cohorts will be selected
Key inclusion criteria (1 listed)
- Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)
Key exclusion criteria (3 listed)
- Refusal of the patient to participate in this study
- Minor patient
- Patient not affiliated to the French social security system
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 |
|---|---|---|
| SA brief descriptive name used to refer to the intervention(s) studiedDetails that can be made public about the intervention | Other | – |
Primary outcome
Frequency of thrombo-embolic events
Time frame: 60months of follow-up after the procedure
The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.
19 secondary outcomes
Efficacy of the procedure
Time frame: One hour after the end of the procedure
Occlusion of the left atrial appendage
Time frame: 3 months
residual peri-device leak
Time frame: 3 months
Percentage of ischemic stroke
Time frame: 1 and 5 years after the procedure
Percentage of transient ischemic attack (TIA)
Time frame: 1 and 5 years after the procedure
Percentage of systemic embolism
Time frame: 1 and 5 years after the procedure
Cardiovascular or unexplained death
Time frame: 1 and 5 years after the procedure
All-cause mortality
Time frame: 1 and 5 years after the procedure
Comparison of the rate of thromboembolic events to expected values
Time frame: 1 and 5 years after the procedure
Rate of complications related or potentially related to the device or the implantation procedure
Time frame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion
Time frame: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion
Time frame: 3 months
Percentage of migration of the device
Time frame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of migration of the device
Time frame: 3 months; 1 year; 5 years
Percentage of device thrombosis
Time frame: 3 months; 1 year; 5 year
Bleeding (all cause)
Time frame: 1 year; 5 year
Bleedings not-related to the procedure or the device
Time frame: 1 year; 5 year
Criteria for Evaluating Associated Antithrombotic Treatments
Time frame: : Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure
Description of the population
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
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 Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Teiger, MD, PhD (00 33 1 49 81 22 51, emmanuel.teiger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of thrombo-embolic events (time frame: 60months of follow-up after the procedure). 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 Jan 2026.