Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

Study Overview
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Brief Summary
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Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new 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 can 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. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate: The efficiency and safety of implanting devices in France The type and duration of antithrombotic treatment prescribed after left atrial appendage closure

Official Title
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Post-approval Study of Percutaneous Left Atrial Appendage Closure

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).ot). Exclusion Criteria: Refusal of the patient to participate in this study and therefore the use of his data Minor patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left atrial appendage closure<br>All patient referred to a department of interventional cardiology for percutaneous left atrial appendage closure may be included. All centers practicing this procedure in France will participate to the present study, whatever the technique used. The patients included in the protocol will be followed as part of the care by centers that will have carried out the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of events at one year | The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes, systemic embolism, unexplained deaths, and cardiovascular death one year 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 concerned will be taken into account, in the case where the same patient would present several events. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Criteria for Evaluating Associated Antithrombotic Treatments | The antithrombotic treatments will be collected at patient's exit, and at 3, 6 and 12 months after implantation. 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 The average duration of anticoagulant and antiplatelet treatments | 1 year of follow up | 
| Description of the population and centers | 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. The type of health facility and the profile of the investigators will be evaluated according to: The place of exercise of the investigators: percentage of physicians practicing in public centers, percentage of physicians practicing in hospital, percentage of physicians practicing in the private sector, percentage of physicians practicing in two sectors The average number of implantations of each device made by the investigators since their first use of each system | At inclusion | 
| Evaluation of implantation indications | The cause of left atrial appendage closure will also be evaluated by comparing the indications of implantation of the device with the indications retained by the CNEDIMTS, taking into account the following combined criteria: CHA2DS2-VASc Score Strict contraindication to anticoagulant therapy Nonvalvular FA | At inclusion | 
| Efficacy at the end 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 | 
| Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up | Percentage of patients in whom the left atrial appendage is effectively closed, | 3 months of follow up | 
| Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up | Percentage of patients with residual leakage | 3 months of follow up | 
| Percentage of ischemic stroke at 1 year of follow up | Percentage of patients with at least one ischemic stroke between the procedure and the 1-year visit | 1 year of follow up | 
| Percentage of transient ischemic attack (TIA) at 1 year of follow up | Percentage of patients presenting at least one TIA between the procedure and the 1-year visit | 1 year of follow up | 
| Percentage of systemic embolism at 1 year of follow up | Percentage of patients with at least one systemic embolism between procedure and follow-up at 1 year | 1 year of follow up | 
| Percentage of cardiovascular or unexplained death at 1 year of follow up | Percentage of patients who had a cardiovascular or unexplained death between the procedure and the 1-year follow-up | 1 year of follow up | 
| Mortality at 1 year of follow up | Percentage of deaths between procedure and follow-up at 1 year | 1 year of follow up | 
| Frequency of cerebral or systemic ischemic events at 1 year of follow up | Comparison of the frequency of cerebral or systemic ischemic events to the predicted theoretical value according to the CHA2DS2-VASc score of the population included | 1 year of follow up | 
| Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up | Rate of complications related or potentially related to the device or the implantation procedure | 7 days of follow up or discharge (if later then D7) | 
| Percentage of pericardial effusion after 7 days of follow up | Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound between the procedure and the discharge from hospital | 7 days of follow up or discharge (if later then D7) | 
| Percentage of migration of the device after 7 days of follow up | Percentage of patients who presented a migration of the device, objectified by the trans-thoracic ultrasound between the procedure and discharge | 7 days of follow up or discharge (if later then D7) | 
| Percentage of device thrombosis at 3 months of follow up | Percentage of patients who presented thrombosis on the device, objectified by transesophageal echography and / or CT scan | 3 months of follow up | 
| Percentage of device migration at 3 months of follow up | Percentage of patients who had a migration of the device, objectified by transesophageal echography and / or CT scan | 3 months of follow up | 
| Rate of complications related or potentially related to the device or procedure after 1 year of follow up | Percentage of patients who had at least one device or procedure complication, such as tamponade requiring surgical drainage, device migration, residual leakage between procedure and 1 year follow-up | 1 year of follow up | 
| Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up | Percentage of device thrombosis or device migrations by trans-thoracic ultrasound | 1 year of follow up | 
| Clinical evolution of the patient at 1 year | The percentage of life threatening, disabling or major hemorrhagic complications that occurred between the procedure and the 1-year follow-up will be recorded. | 1 year of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Left atrial septal closure