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French Database of Left Atrial Appendage Closure

French Database of Left Atrial Appendage Closure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02252861
Acronym
FLAAC
Enrollment
840
Registered
2014-09-30
Start date
2013-10-31
Completion date
2018-09-30
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation and Other Dysrhythmias | Patient

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.

Interventions

OTHERPercutaneous 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.

Sponsors

French association for research in cardiology (ARCARD)
CollaboratorUNKNOWN
Henri Mondor University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France1 year

Secondary

MeasureTime frame
Death rate from cardiovascular disease after left atrial appendage closure1 year
Unexplained Death rate after left atrial appendage closure1 year
Adverse events related to the procedure1 year
Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)1 year
Cost of patient follow-up after left atrial appendage closure1 year
Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)1 year
Cost of the procedure of left atrial appendage closureCosts will be assessed for the duration of hospital stay, an expected average of 3 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026