Ventricular Arrhythmia Suppression Trial

Boston Scientific Corporation0 个研究点目标入组 550 人2003年8月

适应症Tachycardia

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: Tachycardia
发起方: Boston Scientific Corporation
入组人数: 550
主要终点: 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).
状态: 已完成
最后更新: 19年前

概览研究者入排标准结局指标相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2003年8月

结束日期

2005年5月

最后更新

19年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Boston Scientific Corporation

入排标准

入选标准

•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

排除标准

•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

结局指标

主要结局

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).