Cardiac RadiothErapy for VEntricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety of SBRT
研究概览
简要总结
Objective: To explore in our center the feasibility and safety of a SBRT treatment method for VT.
Study population: Patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks.
Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by electrophysiological mapping.
Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival.
Patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. The risk associated with this trial is an increase in toxicity.
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
- •Patient ≥ 18 years
- •Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
- •Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
- •The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
- •Patient must have failed or become intolerant to at least one antiarrhythmic medication
- •Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
- •Ability to give a written informed consent and willingness to return for follow-up
排除标准
- •Pregnancy or breastfeeding
- •Lack of evidence of a myocardial scar triggering the VT
- •Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
- •Advanced symptomatic heart failure defined as NYHA Class IV heart failure
- •Previous radiotherapy with cardiac involvement
- •Life expectancy < 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
- •Any condition that is deemed a contraindication in the judgment of the investigators
结局指标
主要结局
Safety of SBRT
时间窗: From radiotherapy up to 1 year
Measurement of acute and late toxicity assessed using the CTCAE v5.0
Feasibility of SBRT
时间窗: From date of inclusion up to 1 year
Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
次要结局
- Health related quality-of-life(From inclusion up to 1 year)
- Efficacy of SBRT(From inclusion up to 1 year)