StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA): a Phase II Trial of Non-Invasive Treatment of Medically Refractory Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in ICD therapies.
研究概览
简要总结
This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 heart rate and rhythm condition (arrhythmia) who have failed standard of care treatment with medication OR at least one prior invasive catheter ablation procedure.
- •Patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their Radiation Oncologist.
排除标准
- •Patients who have previously received high dose radiotherapy to the target area and cannot safely receive further treatment OR are unable to receive radiotherapy due to other contraindications.
研究组 & 干预措施
Stereotactic ablative radiotherapy (SBRT) Arm
Stereotactic ablative radiotherapy (SBRT) is a type of radiation treatment that delivers precise, high dose radiation to targeted areas. In this study, a single treatment of SBRT will be delivered to the abnormal area of a participant's heart that is causing dangerous heart rate and rhythm changes (arrhythmia).
干预措施: Stereotactic Ablative Radiotherapy (Radiation)
Observational Arm
Potential participants who are eligible to be included in the study, but who choose not to have the SBRT procedure, can still receive standard medical treatment alone and be followed up with study visits and questionnaires.
结局指标
主要结局
Change from Baseline in ICD therapies.
时间窗: Baseline to 18 months follow-up.
Patient cardiac outcomes will be evaluated by changes from baseline in ICD (Implantable Cardioverter-Defibrillator) therapies (ICD shock frequency) following radiotherapy at 1, 3, 6, 12 and 18 months of follow-up.
Change from Baseline in the number or dose of antiarrhythmic medications.
时间窗: Baseline to 18 months follow-up.
Patient cardiac outcomes will be evaluated by changes from baseline in the number or dose of antiarrhythmic medications following radiotherapy at 1, 3, 6, 12 and 18 months of follow-up.
次要结局
- Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.(1 month to 18 months follow-up.)
- Measure patient subjective distress following treatment.(Baseline to 6 months follow-up)
- Overall mortality record.(6 to 18 months follow-up.)
- Rates of hospital admissions.(Baseline to 18 months follow-up.)
- Measure patient quality-of-life during the study.(Baseline to 18 months follow-up.)