Clinical trial NCT03434015: Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )
Official title: Post-approval Study of Percutaneous Left Atrial Appendage Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Left atrial septal closure
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 1051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All French centers practicing percutaneous closure of the left atrial appendage will participate in the present study, whatever the technique used. The patients included in the protocol will be followed as part of the care by the centers that will have carried out the procedure.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of events at one year
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy at the end of the procedure
timeFrame: One hour after the end of the procedure
measure: Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up
timeFrame: 3 months of follow up
measure: Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up
timeFrame: 3 months of follow up
measure: Percentage of ischemic stroke at 1 year of follow up
timeFrame: 1 year of follow up
measure: Percentage of transient ischemic attack (TIA) at 1 year of follow up
timeFrame: 1 year of follow up
measure: Percentage of systemic embolism at 1 year of follow up
timeFrame: 1 year of follow up
measure: Percentage of cardiovascular or unexplained death at 1 year of follow up
timeFrame: 1 year of follow up
measure: Mortality at 1 year of follow up
timeFrame: 1 year of follow up
measure: Frequency of cerebral or systemic ischemic events at 1 year of follow up
timeFrame: 1 year of follow up
measure: Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up
timeFrame: 7 days of follow up or discharge (if later then D7)
measure: Percentage of pericardial effusion after 7 days of follow up
timeFrame: 7 days of follow up or discharge (if later then D7)
measure: Percentage of migration of the device after 7 days of follow up
timeFrame: 7 days of follow up or discharge (if later then D7)
measure: Percentage of device thrombosis at 3 months of follow up
timeFrame: 3 months of follow up
measure: Percentage of device migration at 3 months of follow up
timeFrame: 3 months of follow up
measure: Rate of complications related or potentially related to the device or procedure after 1 year of follow up
timeFrame: 1 year of follow up
measure: Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up
timeFrame: 1 year of follow up
measure: Clinical evolution of the patient at 1 year
timeFrame: 1 year of follow up
measure: Criteria for Evaluating Associated Antithrombotic Treatments
timeFrame: 1 year of follow up
measure: Description of the population and centers
timeFrame: At inclusion
measure: Evaluation of implantation indications
timeFrame: At inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: French Society of Cardio
name: Nicole NACCACHE
role: STUDY_CHAIR
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