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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Primary Purpose

ICD, ICD SHOCKS, DRONEDARONE

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dronedarone arm
Dronedarone
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICD

Eligibility Criteria

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

Inclusion Criteria:

  • Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:

  • CHF NYHA IV OR DECMPENSATED III
  • PERMANENT AF
  • LIVER DYSFUNCION
  • CR CLEARANCE <30

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Dronedrone Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of ICD shocks due to VT in the 6 months period after starting Dronedarone

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2011
    Last Updated
    September 7, 2011
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01430806
    Brief Title
    Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
    Official Title
    Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone. Several case reports have shown promising results with Dronedarone for this patient population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ICD, ICD SHOCKS, DRONEDARONE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dronedrone Arm
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Dronedarone arm
    Intervention Description
    PO Dronedarone 400 mg BID
    Intervention Type
    Drug
    Intervention Name(s)
    Dronedarone
    Intervention Description
    Dronedarone PO 400 MG BID
    Primary Outcome Measure Information:
    Title
    Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Recurernt ICD shocks depite other antiarrhythmic drug therapy Exclusion Criteria: CHF NYHA IV OR DECMPENSATED III PERMANENT AF LIVER DYSFUNCION CR CLEARANCE <30

    12. IPD Sharing Statement

    Learn more about this trial

    Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

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