Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of treatment
研究概览
简要总结
The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.
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
- •Recurrent VTs/VES with significant burden despite guideline-directed therapy
- •Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications
- •AND lack of response or intolerance to antiarrhythmic medication
- •AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)
- •MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.
- •Presence of suitability for radiation therapy with respect to SBRT
- •Age ≥ 18 years
- •Existing informed consent
排除标准
- •Acute myocardial infarction or percutaneous coronary intervention or heart surgery (<3 months before study enrollment)
- •Status post intra-thoracic pre-radiation
- •Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer
- •Advanced symptomatic heart failure (NYHA Class IV)
- •Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)
- •Extensive myocardial scar substrate that would result in too large of a radiation volume
- •Life expectancy < 6 months considering all comorbidities and in the Seattle Heart Failure Model
- •Presence of a Left Ventricular Assist Device (LVAD)
- •Use of cytotoxic medications
- •Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential
结局指标
主要结局
Safety of treatment
时间窗: 30 days
Demonstration of acute (≤ 30 days) safety of non-invasive stereotactic antiarrhythmic radiotherapy for ventricular arrhythmia (STAR). The primary safety endpoint is defined as ≤ 20% rate of severe adverse events according to CTCAE v5.0 criteria
Efficacy of treatment
时间窗: 6 months
The efficacy endpoint is defined by the number of patients experiencing a reduction in ventricular tachycardia episodes, compared to the six-month period prior to SBRT treatment and the six-month period post- SBRT.
次要结局
- Evaluation of changes in the left ventricular ejection fraction(12 months)
- Evaluation of mortality(12 months)
- Assessment of late side effects(12 months)