VAST - Ventricular Arrhythmia Suppression Trial

Tachycardia Clinical Trial

Official title:

Ventricular Arrhythmia Suppression Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158912
• Other study ID #: CR-CA-060903-T
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: November 20, 2006
• Start date: August 2003
• Est. completion date: May 2005

Study information

• Verified date: November 2006
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia

Intervention

Device:
• Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).