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Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)

Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)
Overall Status
Completed
CT.gov ID
NCT04761315
Collaborator
(none)
380
Enrollment
24
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    380 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Atrial high rate new episodes [24 months]

      New episodes of atrial high rate episodes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients in sinus rhythm

    • with or without previous paroxysmal AF

    • with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT)

    • capable of atrial activity monitoring were included in the study

    Exclusion Criteria:

    -Previous documented atrial fibrillation

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
    ClinicalTrials.gov Identifier:
    NCT04761315
    Other Study ID Numbers:
    • TFM 2016-18
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
    cardiac implantable electronic devices
    interatrial block
    P-wave duration
    Additional relevant MeSH terms:
    Embolic Stroke
    Atrial Fibrillation

    Study Results

    No Results Posted as of Feb 18, 2021