VT-ART-P: Ventricular Tachycardia Ablation and RadioTherapy, a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in the number of VT episodes
研究概览
简要总结
The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.
详细描述
By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,
- 12-lead ECG will be performed
- Echocardiography
- CT scan of the chest
- Laboratory tests: NT proBNP, HS Troponin I
- PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.
Participation in the study does not involve any expense for the patient or any compensation.
Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.
The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.
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 refractory VT
- •age > 18 years
- •Patients with ICDs for follow-up
- •Ineligible for heart transplantation.
- •Prognosis of not less than 1 year
- •Ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition
排除标准
- •Evaluation of ICD demonstrating polymorphic VT;
- •Patients with INTERMACS class greater than 4;
- •Patients with LVAD;
- •Patients with active neoplastic disease undergoing oncological treatment.
研究组 & 干预措施
Refractory ventricular tachycardia patients
Patients with refractory VT as defined above
- age > 18 years
- ICD patients for follow-up
- Not eligible for heart transplantation.
- Prognosis not less than 1 year.
They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed
- 12-lead ECG
- Echocardiography
- CT scan of the chest
- Laboratory analysis: NT proBNP, HS Troponin I
- PMK device evaluation and clinical ECG storage.
They will undergo stereotactic treatment on the arrhythmogenic cardiac site
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Change in the number of VT episodes
时间窗: Starting from the week after treatment until 6 months later
The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months.
次要结局
- Change in patient management(Starting from the week after treatment until 6 months later)
- Change in the dosage of antiarrhythmic drugs(Starting from the week after treatment until 6 months later)
- Change in cardiac parameters(Starting from the week after treatment until 6 months later)
研究者
CELLINI FRANCESCO
Medical Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS