STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Recurrence of sustained VT after 3-month blanking period
研究概览
简要总结
A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).
详细描述
Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below.
Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.
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
盲法说明
No masking will be used in the study.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
- •Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
- •Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:
- •3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
- •VT recurrence after the last catheter ablation fulfilling all criteria as follows:
- •4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
- •Signed an Institutional Review Board (IRB)-approved written informed consent
排除标准
- •Age < 20 years
- •Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (< 3 months)
- •Primary electrical disease (channelopathy)
- •Pregnancy or breastfeeding
- •Chronic heart failure with New York Heart Association (NYHA) Class IV
- •Serious comorbidities with presumed life expectancy less than one year
- •Significant peripheral artery disease precluding retrograde aortic mapping
结局指标
主要结局
Recurrence of sustained VT after 3-month blanking period
时间窗: 3 months
Recurrence of sustained VT after 3-month blanking period will be assessed.
次要结局
- VT burden according to implantable device(3 months)
- Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes(24 months)
- Cardiovascular hospitalization(24 months)
- Non-inducibility of VT at 6 months(6 months)
- Electric storm recurrence(24 months)
- Rate of major procedure-related complications (control arm)(24 months)
- Change in echocardiographic indices(24 months)
- Rate of late radiation-induced events(24 months)
- Dynamics of serum troponin level(24 months)
- All-cause death(24 months)
- Extent of scar(6 months)
- Change in quality of life: EQ-5D(24 months)
- Rate of acute post-radiation complications (intervention arm)(24 months)
- Radiation dose(24 months)
- Need of antiemetic drugs(24 months)