Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy of radiation treatment for VT reduction
研究概览
简要总结
Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.
STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
详细描述
Study Hypotheses:
- Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.
- STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
Study Objectives:
- Evaluate the safety of STAR in a local cohort
- Estimate effectiveness of STAR in reducing VT burden
Study Design: Prospective single center, single arm, non-randomized trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and have an implanted cardioverter defibrillator (ICD) with:
- •Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
- •At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated):
- •A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy.
- •B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download.
排除标准
- •Has received prior radiotherapy to the anticipated treatment field
- •Pregnancy
- •Unable to unwilling to provide informed consent
- •New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite
- •Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia.
- •Active coronary ischemia in the last 30 days.
结局指标
主要结局
Efficacy of radiation treatment for VT reduction
时间窗: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.
Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment.
Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.
时间窗: 90 days after treatment
Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction.
次要结局
- Overall mortality(Six months)
研究者
Vikas Kuriachan
Clinical Associate Professor (Cardiology/EP)
University of Calgary