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StimAOD: Direct Oral Anticoagulant Management for Cardiac Device Implantation

Sponsor
Institut Necker Enfants Malades (Other)
Overall Status
Unknown status
CT.gov ID
NCT03879473
Collaborator
(none)
680
Enrollment
1
Location
12.9
Anticipated Duration (Months)
52.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption > 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    680 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation
    Actual Study Start Date :
    Feb 1, 2019
    Anticipated Primary Completion Date :
    Feb 1, 2020
    Anticipated Study Completion Date :
    Mar 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. number of patients with clinically significant pocket hematoma [30 +/- 5 days]

      hematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation.

    Secondary Outcome Measures

    1. number of patients with thromboembolic event [30 +/- 5 days]

      transient ischemic attack, stroke, peripheral embolus, venous thromboembolism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment

    • undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy

    • informed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HEGP Paris France 75000

    Sponsors and Collaborators

    • Institut Necker Enfants Malades

    Investigators

    • Principal Investigator: Anne-Céline Martin, MD, PhD, INSERM 1140

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne-Céline MARTIN, Doctor, Institut Necker Enfants Malades
    ClinicalTrials.gov Identifier:
    NCT03879473
    Other Study ID Numbers:
    • CV185-614
    First Posted:
    Mar 18, 2019
    Last Update Posted:
    Mar 18, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 18, 2019