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

French Cardiology Society

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT03434015

3528-NI

Details and patient eligibility

About

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

Enrollment: 1,051 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,051 participants in 1 patient group

Left atrial appendage closure

Description:

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.