French Database of Left Atrial Appendage Closure

Completed

• Conditions: Atrial Fibrillation and Other Dysrhythmias | Patient
• Interventions: Other: Percutaneous Left Atrial Appendage Closure in routine care

• Registration Number: NCT02252861
• Lead Sponsor: Henri Mondor University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Unexplained Death rate after left atrial appendage closure	1 year
Cost of patient follow-up after left atrial appendage closure	1 year
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
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
Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)	1 year

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France