VAST - Ventricular Arrhythmia Suppression Trial

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158912
First received: September 7, 2005
Last updated: November 20, 2006
Last verified: November 2006
  Purpose

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 Intervention Phase
Tachycardia
Device: Implantable Cardioverter Defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Ventricular Arrhythmia Suppression Trial

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

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).

Estimated Enrollment: 550
Study Start Date: August 2003
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158912

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

No publications provided

ClinicalTrials.gov Identifier: NCT00158912     History of Changes
Other Study ID Numbers: CR-CA-060903-T
Study First Received: September 7, 2005
Last Updated: November 20, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014