Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
研究概览
简要总结
Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Following this Phase I lead-in, results will be presented to the FDA for review. Only upon favorable analysis by the FDA committee, and with written explicit permission, will the Phase II randomized portion ensue. This is to act as a safety and efficacy safeguard and has is addressed more thoroughly in the Statistical Analysis Plan of this protocol.
Phase II: A 1:1 randomized Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care; Figure 3). Standard of care is defined as nationally recognized appropriate next treatment strategies for medical and catheter-ablation refractory structural cardiac VT that is assessed and judged appropriate for the patient by his/her treating cardiologist. This includes repeat catheter ablation (intravascular and/or epicardial catheter ablation), placement of left-ventricular assist device (LVAD), heart transplant, or further medical management (e.g. antiarrhythmic drug modulation/continuation). Randomization will be performed through the Clinical Trial Conduct (CTC) website.
详细描述
Primary Objectives Phase I:
-Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). Ensure safety and treatment efficacy.
Primary Objectives Phase II:
- Investigate overall toxicity with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
- Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options.
Primary Objectives Phase I:
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
- •Age 18 years or older
- •Diagnosis of recurrent sustained monomorphic VT (MMVT) in the setting of structural heart disease.
- •ICD placement and at least two (2) episodes of recurrencerecurrent sustained MMVT that are terminated by anti-tachycardia pacing (ATP) or ICD shocks confirmed by device interrogation in the preceding 3 months, since the last VT ablation procedure in subjected who have failed catheter ablation.
- •Failed at least 1 anti-arrhythmic medication (not including beta-blockers) as evidenced by persistent VT (including amiodarone and/or sotalol)
- •At least 1 attempted catheter ablation procedure with voltage and/or activation 3D mapping. For patients with ischemic cardiomyopathy this would include failure of at least one endocardial ablation performed at an experienced center. For patients with non-ischemic cardiomyopathy, both endocardial and epicardial ablation should have been attempted unless epicardial ablation/mapping is not feasible (e.g. patient tolerance, deemed futile by EP, prior cardiac surgery).
- •Patients are eligible regardless of past or present oncologic history (however, please refer to exclusion criterion #1 below, regarding life-expectancy of at least 12 months in the absence of VT)
排除标准
- •Unlikely to live at least 12 months in the absence of VT, as assessed by physicians
- •Heart failure dependent on ionotropes
- •Left ventricular assist device
- •Polymorphic VT
- •Ventricular fibrillation
- •5 or more VT morphologies during stimulation testing suggestive of more than one arrhythmogenic substrate
- •Prior radiation treatment to the chest for any reason
- •Last invasive catheter ablation attempt <2 weeks
- •Lack of ICD data in preceding 3 months
- •Unable/unwilling to provide informed consent
- •Idiopathic VT
- •Women who are pregnant
- •Heart transplant
- •Active ischemia or other reversible causes of VT
- •Active non-cardiovascular illness or systemic infection
- •Cardiogenic shock
- •Presence of incessant VT that is hemodynamically unstable
- •Acute heart failure exacerbation
- •Revascularization in the past 30 days
- •Left ventricular ejection fraction <15%
- •Scar tissue exceeding 80cc in volume planning treatment volume (PTV) ≥300cc.
结局指标
主要结局
The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点