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Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

Primary Purpose

Atrio-Ventricular Block

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pacemaker Implantation
Sponsored by
Osaka General Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrio-Ventricular Block

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the patients who need pacemaker implantation for atrio-ventricular block

Exclusion Criteria:

  • Pregnancy, left ventricular dysfunction at the time of implantation

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hospitalization for the heart failure

    Secondary Outcome Measures

    incidence of atrial fibrillation

    Full Information

    First Posted
    July 1, 2008
    Last Updated
    July 2, 2008
    Sponsor
    Osaka General Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00709774
    Brief Title
    Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block
    Official Title
    Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    June 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Osaka General Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrio-Ventricular Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Pacemaker Implantation
    Intervention Description
    Implantation of right ventricular lead at septal or apex.
    Primary Outcome Measure Information:
    Title
    Hospitalization for the heart failure
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    incidence of atrial fibrillation
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the patients who need pacemaker implantation for atrio-ventricular block Exclusion Criteria: Pregnancy, left ventricular dysfunction at the time of implantation

    12. IPD Sharing Statement

    Learn more about this trial

    Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

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