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VAST - Ventricular Arrhythmia Suppression Trial

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ClinicalTrials.gov Identifier: NCT00158912
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 22, 2006
Sponsor:
Information provided by:
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Tachycardia Device: Implantable Cardioverter Defibrillator Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Ventricular Arrhythmia Suppression Trial
Study Start Date : August 2003
Study Completion Date : May 2005



Primary Outcome Measures :
  1. 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).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158912


Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Paul Friedman, MD Mayo Clinic

ClinicalTrials.gov Identifier: NCT00158912     History of Changes
Other Study ID Numbers: CR-CA-060903-T
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 22, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes