Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Acute toxicity evaluated using CTCAE v5.0 scale
研究概览
简要总结
Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
详细描述
The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.
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
- •Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
- •Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
- •At least one episode of monomorphic VT registered in electrophysiological examination.
- •Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
- •Patient must be able to understand and be willing to sign a written informed consent document.
排除标准
- •Heart failure requiring inotropic treatment or mechanical assistance
- •Arrhythmia due to cardiac channelopathy
- •Reversible source of arrhythmia
- •NYHA (New York Heart Association) stage IV hearth failure
- •Hearth infarction or cardiac surgery in last 3 months
- •Life expectancy <6 months
- •Polymorphic VT
- •Pregnancy
- •Prior radiotherapy to the thoracic region (relative contraindication)
- •Failure to induce VT during electrophysiological examination
结局指标
主要结局
Acute toxicity evaluated using CTCAE v5.0 scale
时间窗: 3 months
The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.
次要结局
- Late toxicity and mortality(24 months)
- Efficacy of the treatment(24 months)
- Biochemical markers of cardiac injury(24 months)
- Anti-arrhythmic drugs uptake(24 months)
- Target volume delineation(24 months)
- Cardiac injury(24 months)
研究者
Slawomir Blamek
dr hab. n. med.
Maria Sklodowska-Curie National Research Institute of Oncology