EHPAFAVE: Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

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

Study Details

Study Description

Brief Summary

Due to the high thrombotic risk during the atrial fibrillation procedure, new guidelines have been proposed to maintain direct oral anticoagulant therapy during the perioperative period. This resulted in a significant change in the activated clotting time (ACT) at the beginning of the procedure, making it difficult to assess the level of heparinization during the procedure. The main objective of this study was to evaluate the correlation between laboratory hemostatic parameters, ACT and the dose of unfractionated heparin received. The secondary objective of this study was to correlate these results with hemorrhagic or thrombotic complications.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated 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
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated 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

    SiteCityStateCountryPostal Code
    1Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de StrasbourgStrasbourgFrance67091

    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:
    Nov 19, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021