VAST - Ventricular Arrhythmia Suppression Trial - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00158912

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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Ventricular Arrhythmia Suppression Trial

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

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

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

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009