Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia in Chagas Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of SBRT for the treatment of Ventricular Tachycardia
研究概览
简要总结
This is an observational study of 10 Chagas Disease patients with Ventricular Tachycardia that have failed prior catheter ablation or have this procedure contraindicated due to clinical status. Those patients will underwent to Stereotactic Body Radiation Therapy (SBRT) targeting the area of the heart of the VT circuits. Radioablation target will be defined based on prior ablation electroanatomical mapping, VT morphology, pre-acquired imaging (CT angiogram, Cardiac Magnetic Resonance), current imaging reconstructed and integrated to electroanatomical mapping and a EP study to define current VT morphologies. Gross targeted volume (GTV), internal targeted volume (ITV) and planning targeted volume (PTV) will be defined and calculated and a single 25Gy dose will be delivered to the PTV. Patients will be followed initially for one year and efficacy endpoint will be rate of VT recurrence, time to recurrence and VT burden. Safety endpoint will be the occurrence of any adverse effect related to SBRT.
详细描述
Enrollment A patient that fulfill all inclusion criteria (especially diagnosis of Chagas heart disease including positive serology, recurrent sustained ventricular tachycardia requiring therapy and failed or is ineligible for catheter ablation and had no exclusion criteria will be identified as a candidate for participation in this study while receiving care at Instituto do Coração, São Paulo, Brazil. The clinical team will contact the patient in-person and propose study participation and Consent Form will be applied.
A total of 10 patients will be enrolled in the current study. At the time of enrollment, baseline information pertaining to symptoms and details regarding clinical presentation, imaging, and heart catheterization procedures will be obtained from examination of their medical record and recorded in a Redcap database.
Pre-radiation Imaging and Definition of Treatment Area:
All patients will perform a cardiac MRI with 3D LGE sequence to be imported in the ADAS 3D software. After MRI acquisition, images will be imported in the software, segmented and the channels will be identified using an specific tool in the software. After channels and scar identified the quality of reconstruction and channel identification will be manually validated by one of the investigators. If the image is considered adequate, the scar, the chambers and the channels will be exported in VTK format. If the reconstruction is defined as a poor quality by the investigators, last VT ablation procedure and or ECGs of the VT and cardiac, mapping data from prior ablation, prior MRI or cardiac CT analyzing wall thickness will be used to design treatment area . Additionally, areas of scar or infarction identified by previous electroanatomic mapping (voltage maps), imaging (CT, echocardiography, and/or nuclear imaging) that are likely the source of VT based on mapping or ECG analysis will be targeted. The area of interest will be determined by both the treating cardiologist and radiation oncologist.
Radiation treatment:
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
- •Diagnosis of Chagas heart disease including positive serology
- •Recurrent sustained ventricular tachycardia requiring therapy due to symptoms, ICD shocks, or requiring hospitalization.
- •Age>18 years.
- •Able to give written, informed consent. If the patient requires continuous sedation/anesthesia for arrhythmia control consent can be provided by the next of kin.
- •Medically fit to undergo radiation planning and treatment sessions.
- •Failed antiarrhythmic medications due to VT recurrence, drug intolerance, or contraindication.
- •Failed prior catheter ablation due to arrhythmia recurrence or ineligible for endocardial or epicardial catheter ablation (LV thrombus, epicardial adhesion, megacolon, prior open chest surgery)
排除标准
- •Cardiogenic shock not due to VT with no possibility of heart transplant or ventricular assist device.
- •Inability for patient to be adequately immobilized for radiation planning and treatment.
- •Repeat catheter ablation is felt to be a reasonable option.
- •Previous radiation to the chest.
- •Pregnancy or refusal to use contraception.
结局指标
主要结局
Safety of SBRT for the treatment of Ventricular Tachycardia
时间窗: 12 months
Incidence of cardiac and extra-cardiac adverse effects related to SBRT
Efficacy of SBRT for the treatment of Ventricular Tachycardia
时间窗: 12 months
Rate of VT recurrence after a blanking period of 6 weeks following SBRT
次要结局
- VT Burden(12 months)
- Time to VT Recurrence(12 months)
- Mortality(12 months)
- Cardiac Mortality(12 months)
研究者
Mauricio Ibrahim Scanavacca
Principal Investigator
University of Sao Paulo General Hospital