French Database of Left Atrial Appendage Closure

NCT ID: NCT02252861

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation and Other Dysrhythmias | Patient

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Left Atrial Appendage Closure

Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care

Percutaneous Left Atrial Appendage Closure in routine care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French association for research in cardiology (ARCARD)

UNKNOWN

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Philippe Le Corvoisier

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanuel Teiger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 34051135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29540492 (View on PubMed)

Other Identifiers

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FLAAC

Identifier Type: -

Identifier Source: org_study_id

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