STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- 3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
研究概览
简要总结
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).
详细描述
The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 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 (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
- •Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
- •Prior ≥1 catheter ablation procedure for monomorphic VT
- •VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
- •Age ≥30 years
- •Signed an IRB-approved (Institutional Review Board) written informed consent
排除标准
- •Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months)
- •Primary electrical disease (channelopathy)
- •Reversible cause of VT (e.g. drug-induced, intoxications, etc)
- •Pregnancy or breastfeeding
- •Chronic heart failure 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
- •History of chest radiotherapy
结局指标
主要结局
3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
时间窗: 53 months
The rate of acute (\<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
Change of sustained VT burden in three 3-month intervals
时间窗: 50 months
Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold
时间窗: 50 months
All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
次要结局
- Composite endpoint of all-cause death and appropriate ICD shock(50 months)
- Electric storm recurrence(53 months)
- Change in quality of life(53 months)
- Cardiovascular hospitalisations(53 months)