Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 主要终点
- Recurrence (Recurrence of any ventricular tachycardia)
研究概览
简要总结
Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
- •history of ischemic heart disease
- •ICD carrier or ICD implantation planned after the ablation
- •informed written consent
排除标准
- •current unstable angina as defined by current european guidelines
- •AMI < 30 days or in case of incessant VT < 14 days
- •absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
- •significant coronary stenosis approachable and clinically relevant for intervention
- •presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
- •previous pericarditis
- •presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
- •previous thoracic radiation therapy
- •contra-indication for general anaesthesia
- •age below 18 years
结局指标
主要结局
Recurrence (Recurrence of any ventricular tachycardia)
时间窗: 2 years
Recurrence of any ventricular tachycardia: any appropriate ICD therapy or VT \> 30 seconds of duration recorded by ICD interrogations or on clinical event recorded by electrocardiogram with an initial blanking period of 1 week after the ablation procedure
次要结局
- procedure success(2 years)
- procedure related (serious) adverse events(30 days)
- procedure time, fluoroscopy and radiofrequency time(one day)
- time to recurrence to ventricular arrhythmia(2 years)
- number of appropriate ICD therapy on follow-up(2 years)
- number of ventricular arrhythmia related hospitalizations(2 years)
- free of antiarrhythmic drugs on follow-up(2 years)
- repeat procedure(2 years)
- incessant VT or VT storm on follow-up(2 years)
- mortality(2 years)
研究者
Astrid Hendriks
MD
Erasmus Medical Center