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NCT Number: NCT05565209

Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)

Exclusion criteria

  • Refusal of the patient to participate in this study
  • Minor patient
  • Patient not affiliated to the French social security system

Treatment and study plan

SA brief descriptive name used to refer to the intervention(s) studied

Other

Details that can be made public about the intervention

Primary outcomes

  1. Frequency of thrombo-embolic events

    Time frame: 60months of follow-up after the procedure

    The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.

Secondary outcomes

  1. Efficacy of the procedure

    Time frame: One hour after the end of the procedure

    : At the end of the procedure, the efficiency of the procedure will be described by the percentage of success of the procedure. The successful procedure is defined by a successful implantation of the device in the left atrial appendage without presaging its occlusive character.

    One hour after the end of the procedure

  2. Occlusion of the left atrial appendage

    Time frame: 3 months

    The percentage of left atrial appendage occlusion is defined as the percentage of patients where left atrial appendage is efficiently closed at by transesophageal echography and / or CT scan Time Frame: 3 months

  3. residual peri-device leak

    Time frame: 3 months

    The percentage a patients with 3 months residual peri-device leak will be determined at transesophageal echography and / or CT scan

  4. Percentage of ischemic stroke

    Time frame: 1 and 5 years after the procedure

    Percentage of patients with at least one ischemic stroke during the study

  5. Percentage of transient ischemic attack (TIA)

    Time frame: 1 and 5 years after the procedure

    Percentage of patients presenting at least one systemic embolism during the study

  6. Percentage of systemic embolism

    Time frame: 1 and 5 years after the procedure

    Percentage of patients presenting at least one systemic embolism during the study

  7. Cardiovascular or unexplained death

    Time frame: 1 and 5 years after the procedure

    Percentage of patients who had a cardiovascular or unexplained death during the study

  8. All-cause mortality

    Time frame: 1 and 5 years after the procedure

    percentage of all cause deaths

  9. Comparison of the rate of thromboembolic events to expected values

    Time frame: 1 and 5 years after the procedure

    the observed rate of thromboembolic event will be compared to the expected value, according the individual patients CHA2DS2-VASc scores

  10. Rate of complications related or potentially related to the device or the implantation procedure

    Time frame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)

    : Rate of complications related or potentially related to the device or the implantation procedure

  11. Percentage of pericardial effusion

    Time frame: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)

    Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound

  12. Percentage of pericardial effusion

    Time frame: 3 months

    Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound

  13. Percentage of migration of the device

    Time frame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)

    Percentage of patients who presented a migration of the device, objectified by echocardiography and / or CT scan

  14. Percentage of migration of the device

    Time frame: 3 months; 1 year; 5 years

    : Percentage of patients who presented a migration of the device, objectified by the echocardiography and / or CT scan

  15. Percentage of device thrombosis

    Time frame: 3 months; 1 year; 5 year

    Percentage of patients who presented a thrombosis on the device, objectified by transesophageal echography and / or CT scan

  16. Bleeding (all cause)

    Time frame: 1 year; 5 year

    Percentage of patients who presented a bleeding

  17. Bleedings not-related to the procedure or the device

    Time frame: 1 year; 5 year

    Percentage of patients who presented a bleeding not-related to the procedure or the device

  18. Criteria for Evaluating Associated Antithrombotic Treatments

    Time frame: : Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure

    The antithrombotic treatments will be collected at different follow-up times.

    The type and duration of anti-thrombotic treatments will be documented using the combined criteria:

    • Percentage of patients on injectable or oral anticoagulants and antiplatelet agents at different follow-up times
    • Percentage of patients on injectable or oral anticoagulants at different follow-up times
    • The percentage of patients on platelet antiaggregants in single or dual therapy at different follow-up times

  19. Description of the population

    Time frame: At inclusion

    Demographic and clinical characteristics of the patients will be collected and described, such as: age, sex, medical and surgical history, cardiovascular pharmacological treatments, comorbidities, indication of left atrial closure, HAS-BLED and CHA2DS2-VASc scores, anatomical features of the left atrial appendage at inclusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Teiger, MD, PhD

CONTACT

[email protected]

00 33 1 49 81 22 51

Philippe Le Corvoisier, MD, PhD

CONTACT

[email protected]

+33149813790

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: FLAAC3

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
Jan 15, 2026

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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