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VAST - Ventricular Arrhythmia Suppression Trial

Primary Purpose

Tachycardia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD Patients who sign and date a Patient Informed Consent prior to study enrollment Patients who remain in the clinical care of physicians of their implanting center Exclusion Criteria: Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization Patients who previously had an ICD Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D) Patients whose life expectancy is less than 12 months due to other medical conditions Patients who are expected to receive a heart transplant during the duration of the study Patients who have or who are likely to receive a tricuspid or other valve prosthesis Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    November 20, 2006
    Sponsor
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00158912
    Brief Title
    VAST - Ventricular Arrhythmia Suppression Trial
    Official Title
    Ventricular Arrhythmia Suppression Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Boston Scientific Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tachycardia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    550 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Implantable Cardioverter Defibrillator
    Primary Outcome Measure Information:
    Title
    The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD Patients who sign and date a Patient Informed Consent prior to study enrollment Patients who remain in the clinical care of physicians of their implanting center Exclusion Criteria: Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization Patients who previously had an ICD Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D) Patients whose life expectancy is less than 12 months due to other medical conditions Patients who are expected to receive a heart transplant during the duration of the study Patients who have or who are likely to receive a tricuspid or other valve prosthesis Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Friedman, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    VAST - Ventricular Arrhythmia Suppression Trial

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