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Completed

NCT Number: NCT02252861

French Database of Left Atrial Appendage Closure

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.

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Key information

Conditions

Atrial Fibrillation and Other Dysrhythmias | Patient Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Left Atrial Appendage Closure in routine care

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Collaborators

  • French association for research in cardiology (ARCARD)

Registry information

Acronym: FLAAC

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2014
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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