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

NCT ID: NCT03434015

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1051 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2021-10-07

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

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Left atrial appendage closure

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole NACCACHE

Role: STUDY_CHAIR

French Society of Cardio

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

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Other Identifiers

3528-NI

Identifier Type: -

Identifier Source: org_study_id