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French Database of Left Atrial Appendage Closure (FLAAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252861
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
French association for research in cardiology (ARCARD)
Information provided by (Responsible Party):
Philippe Le Corvoisier, Henri Mondor University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Atrial Fibrillation and Other Dysrhythmias | Patient Other: Percutaneous Left Atrial Appendage Closure in routine care

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: French Database of Left Atrial Appendage Closure
Actual Study Start Date : October 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France [ Time Frame: 1 year ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252861


Locations
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France
Henri Mondor Hospital
Creteil, France, 94000
Sponsors and Collaborators
Henri Mondor University Hospital
French association for research in cardiology (ARCARD)
Investigators
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Principal Investigator: Emmanuel Teiger, MD, PhD emmanuel.teiger@hmn.aphp.fr
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philippe Le Corvoisier, MD, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT02252861    
Other Study ID Numbers: FLAAC
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes