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Completed

NCT Number: NCT03434015

Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new 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 can 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. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:

* The efficiency and safety of implanting devices in France * The type and duration of antithrombotic treatment prescribed after left atrial appendage closure

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac 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, France

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).ot).

Exclusion criteria

  • Refusal of the patient to participate in this study and therefore the use of his data
  • Minor patient

Treatment and study plan

Primary outcomes

  1. Frequency of events at one year

    Time frame: 1 year

    The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes, systemic embolism, unexplained deaths, and cardiovascular death one year 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 concerned will be taken into account, in the case where the same patient would present several events.

Secondary outcomes

  1. Efficacy at the end 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.

  2. Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up

    Time frame: 3 months of follow up

    Percentage of patients in whom the left atrial appendage is effectively closed,

  3. Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up

    Time frame: 3 months of follow up

    Percentage of patients with residual leakage

  4. Percentage of ischemic stroke at 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of patients with at least one ischemic stroke between the procedure and the 1-year visit

  5. Percentage of transient ischemic attack (TIA) at 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of patients presenting at least one TIA between the procedure and the 1-year visit

  6. Percentage of systemic embolism at 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of patients with at least one systemic embolism between procedure and follow-up at 1 year

  7. Percentage of cardiovascular or unexplained death at 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of patients who had a cardiovascular or unexplained death between the procedure and the 1-year follow-up

  8. Mortality at 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of deaths between procedure and follow-up at 1 year

  9. Frequency of cerebral or systemic ischemic events at 1 year of follow up

    Time frame: 1 year of follow up

    Comparison of the frequency of cerebral or systemic ischemic events to the predicted theoretical value according to the CHA2DS2-VASc score of the population included

  10. Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up

    Time frame: 7 days of follow up or discharge (if later then D7)

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

  11. Percentage of pericardial effusion after 7 days of follow up

    Time frame: 7 days of follow up or discharge (if later then D7)

    Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound between the procedure and the discharge from hospital

  12. Percentage of migration of the device after 7 days of follow up

    Time frame: 7 days of follow up or discharge (if later then D7)

    Percentage of patients who presented a migration of the device, objectified by the trans-thoracic ultrasound between the procedure and discharge

  13. Percentage of device thrombosis at 3 months of follow up

    Time frame: 3 months of follow up

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

  14. Percentage of device migration at 3 months of follow up

    Time frame: 3 months of follow up

    Percentage of patients who had a migration of the device, objectified by transesophageal echography and / or CT scan

  15. Rate of complications related or potentially related to the device or procedure after 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of patients who had at least one device or procedure complication, such as tamponade requiring surgical drainage, device migration, residual leakage between procedure and 1 year follow-up

  16. Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up

    Time frame: 1 year of follow up

    Percentage of device thrombosis or device migrations by trans-thoracic ultrasound

  17. Clinical evolution of the patient at 1 year

    Time frame: 1 year of follow up

    The percentage of life threatening, disabling or major hemorrhagic complications that occurred between the procedure and the 1-year follow-up will be recorded.

  18. Criteria for Evaluating Associated Antithrombotic Treatments

    Time frame: 1 year of follow up

    The antithrombotic treatments will be collected at patient's exit, and at 3, 6 and 12 months after implantation.

    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
    • The average duration of anticoagulant and antiplatelet treatments

  19. Description of the population and centers

    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.

    The type of health facility and the profile of the investigators will be evaluated according to:

    • The place of exercise of the investigators: percentage of physicians practicing in public centers, percentage of physicians practicing in hospital, percentage of physicians practicing in the private sector, percentage of physicians practicing in two sectors
    • The average number of implantations of each device made by the investigators since their first use of each system

  20. Evaluation of implantation indications

    Time frame: At inclusion

    The cause of left atrial appendage closure will also be evaluated by comparing the indications of implantation of the device with the indications retained by the CNEDIMTS, taking into account the following combined criteria:

    • CHA2DS2-VASc Score
    • Strict contraindication to anticoagulant therapy
    • Nonvalvular FA

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

Post-approval Study of Percutaneous Left Atrial Appendage Closure

Acronym: FLAAC-2

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 15, 2018
Registry last updated
Sep 16, 2022

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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