Clinical trial NCT02252861: French Database of Left Atrial Appendage Closure
Official title: French Database of Left Atrial Appendage Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation and Other Dysrhythmias | Patient
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
Collaborators: name: French association for research in cardiology (ARCARD)
First posted: 2014-09-30
Enrollment: 840
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 patients referred for percutaneous Left Atrial Appendage Closure to one of the French centers involved in this database

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)
timeFrame: 1 year
measure: Death rate from cardiovascular disease after left atrial appendage closure
timeFrame: 1 year
measure: Unexplained Death rate after left atrial appendage closure
timeFrame: 1 year
measure: Adverse events related to the procedure
timeFrame: 1 year
measure: Cost of the procedure of left atrial appendage closure
timeFrame: Costs will be assessed for the duration of hospital stay, an expected average of 3 days
measure: Cost of patient follow-up after left atrial appendage closure
timeFrame: 1 year
measure: Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: emmanuel.teiger@hmn.aphp.fr
name: Emmanuel Teiger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.