Substrate Modification Study in Patients Getting an ICD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 14
- 主要终点
- Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period
研究概览
简要总结
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions.
The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.
- •Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.
- •Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:
- •Hypotensive VT without major neurologic dysfunction;
- •Syncope; or
- •Cardiac arrest.
排除标准
- •Age < 18 years or > 80 years
- •Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram
- •Acute myocardial infarction within the preceding 2 months
- •Class IV New York Heart Association (NYHA) heart failure
- •Valvular heart disease or mechanical heart valve precluding access to the left ventricle
- •Unstable angina
- •Cardiac surgery within the past 2 months
- •Serum creatinine > 220 mmol/L (2.5 mg/dL)
- •Thrombocytopenia or coagulopathy
- •Contraindication to heparin
- •Pregnancy
- •Acute illness or active systemic infection
- •Other disease process likely to limit survival to less than 12 months
- •Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study
- •Participation in another investigational study
- •Unwillingness to participate or lack of availability for follow-up
结局指标
主要结局
Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period
时间窗: 12 Months
次要结局
- All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)(12 Months)
- Severe clinical events(12 Months)
- Number of hospital readmissions due to a cardiac indication(12 Months)
- Quality of life(12 Months)