VAST - Ventricular Arrhythmia Suppression Trial

November 20, 2006 updated by: Boston Scientific Corporation

Ventricular Arrhythmia Suppression Trial

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment

550

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 22, 2006

Last Update Submitted That Met QC Criteria

November 20, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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