NCT00158912

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

November 22, 2006

Status Verified

November 1, 2006

First QC Date

September 7, 2005

Last Update Submit

November 20, 2006

Conditions

Tachycardia

Outcome Measures

Primary Outcomes (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).

Interventions

Implantable Cardioverter DefibrillatorDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tachycardia

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Paul Friedman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2003

Study Completion

May 1, 2005

Last Updated

November 22, 2006

Record last verified: 2006-11