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EHPAFAVE: Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT05128110
Collaborator
(none)
15
Enrollment
1
Location
12
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Study of Hemostasis During the Atrial Fibrillation Ablation Procedure
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Nov 30, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests [Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients over 18 years-old

    • with an atrial fibrillation

    • Operated for an atrial fibrillation procedure in the University hospital of Strasbourg

    • Without interruption of the direct oral anticoagulant

    • For whom extended biological assessment has been made in routine practice

    Exclusion Criteria:
    • Patients who refused the use of their data for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Charles-Ambroise TACQUARD, MD, Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05128110
    Other Study ID Numbers:
    • 7717
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Atrial fibrillation
    Ablation
    ACT
    Heparin
    Direct oral anticoagulant
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jan 26, 2022