Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
研究概览
简要总结
The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.
详细描述
The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (ICD). The patients have not been using using chronic antiarrhythmic medication. Primary end point is number of ICD therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. Secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues. Total length of the follow-up is at least two years.
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
- •Patients 18-80 years of age with prior myocardial infarction and ICD (single chamber, dual chamber ICD or ICD with biventricular pacing capability (CRT-D)) for primary or secondary prevention of sudden cardiac death (SCD), who have had at least two documented episodes of sustained VT or VF and no chronic amiodarone treatment for ventricular tachyarrhythmias
排除标准
- •Age less than 18 years or more than 80 years
- •Non-ischemic cardiomyopathy
- •Ongoing chronic treatment of ventricular tachyarrhythmias with amiodarone, intolerance/contraindication to all class III antiarrhythmic drugs (i.e., intolerance/contraindication to one class III agents is not excluding the patient if another one can be used)
- •Contraindication to endocardial catheter ablation (e.g., intracavitary thrombi, contraindication to perioperative anticoagulation)
- •Previous VT/VF ablation
- •Open heart surgery within 3 months
- •Prosthetic heart valve
- •Planned revascularization (PCI or CABG)
- •Surgery for structural heart disease or heart transplantation
- •Pregnancy or planned pregnancy within the follow-up period
- •Secondary cause for VT/VF (e.g., acute myocardial infarction)
- •Patient does not want to participate
- •Life expectancy less than 12 months
研究组 & 干预措施
Radiofrequency catheter ablation
Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping
干预措施: Radiofrequency catheter ablation (Procedure)
Antiarrhythmic drug therapy
Amiodarone (or sotalol) tablet by mouth for the duration of the study
干预措施: Antiarrhythmic drug therapy (Drug)
结局指标
主要结局
Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes
时间窗: 12 months
• Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months
次要结局
- All cause mortality(12 and 24 months)
- Number of electrical storm episodes(12 and 24 months)
- Number of inappropriate ICD therapies(up to 24 months)
- Cardiovascular mortality(12 and 24 months)
- Time to first hospitalization and number of hospital days(12 and 24 months)
- Time to reablation(up to 24 months)
- Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires(12 and 24 months)
- Number of non-sustained VT episodes(12 and 24 months)
- Comparative cost-effectiveness of the therapies(12 and 24 months)
- Quality of life measured By SF-36 and EQ5D questionnaires(12 and 24 months)
- Time to first VT/VF(up to 24 months)
- Number of atrial fibrillation and other supraventricular arrhythmia episodes(up to 24 months)
- Number of appropriate ICD therapies and sustained VT/VF episodes(24 months)