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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
SBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia
Policlinico Universitario Agostino Gemelli IRCSS
Rome, RM, Italy
Change in the number of VT episodes
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.
Time frame: Starting from the week after treatment until 6 months later
Change in patient management
Reduction in VT episodes compared with the pre-treatment period as reported by ICD query in the shortest observational period. In more detail: the number of VT episodes in the last month before treatment will be compared with the number of VT episodes recorded in the third (3rd) month after treatment.
Time frame: Starting from the week after treatment until 6 months later
Change in the dosage of antiarrhythmic drugs
Total reduction/suspension of antiarrhythmic drugs compared with baseline (before radiotherapy).
Time frame: Starting from the week after treatment until 6 months later
Change in cardiac parameters
Improvement in cardiac parameters compared with baseline: LVEF, left ventricular diastolic volume
Time frame: Starting from the week after treatment until 6 months later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.