NCT Number: NCT00158912
VAST - 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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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).
Sponsors and collaborators
Lead sponsor
Boston Scientific Corporation
Industry
Registry information
Official study title
Ventricular Arrhythmia Suppression Trial
Important dates
- Study start
- 2003
- Study completion
- 2005
- First posted
- Sep 12, 2005
- Registry last updated
- Nov 22, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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