French Database of Left Atrial Appendage Closure (FLAAC)

Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.

This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.

This database is strictly observational.

Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation and Other Dysrhythmias | Patient
• Intervention / Treatment: Other: Percutaneous Left Atrial Appendage Closure in routine care

• Study Type: Observational
• Enrollment (Actual): 840

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94000
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for percutaneous Left Atrial Appendage Closure to one of the French centers involved in this database

Description

Inclusion Criteria:

• Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care
• Signature of an inform consent form for inclusion of data recorded during care in the database

Exclusion Criteria:

none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Left Atrial Appendage Closure; Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care	Other: Percutaneous Left Atrial Appendage Closure in routine care; The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)	1 year
Death rate from cardiovascular disease after left atrial appendage closure	1 year
Unexplained Death rate after left atrial appendage closure	1 year
Adverse events related to the procedure	1 year
Cost of the procedure of left atrial appendage closure	Costs will be assessed for the duration of hospital stay, an expected average of 3 days
Cost of patient follow-up after left atrial appendage closure	1 year
Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)	1 year

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital
• Collaborators: French association for research in cardiology (ARCARD)
• Investigators: Principal Investigator: Emmanuel Teiger, MD, PhD, emmanuel.teiger@hmn.aphp.fr

Publications and helpful links

General Publications

• Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Spaulding C, Armero S, Champagnac D, Bhugaloo H, Ternacle J, Lellouche N, Audureau E, Le Corvoisier P; French national Left Atrial Appendage Closure registry (FLAAC) investigators. Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry. Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.
• Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Pasquie JL, Rioufol G, Lepillier A, Elbaz M, Horvilleur J, Brenot P, Pierre B, Le Corvoisier P; French National Left Atrial Appendage Closure Registry (FLAAC) Investigators. Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events. Circ Cardiovasc Interv. 2018 Mar;11(3):e005841. doi: 10.1161/CIRCINTERVENTIONS.117.005841.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: FLAAC