Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial. The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT. Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Multimodal-imaging guided SBRT for VT ablation.
Centro Cardiologico Monzino, IRCCS
Milan, MI, Italy
RECRUITINGIstituto Europeo di Oncologia, IRCCS
Milan, MI, Italy
ACTIVE_NOT_RECRUITINGSBRT safety during 12 month follow-up
Serious adverse events will be defined using CTCAE v4.0 criteria.
Time frame: 12 months
SBRT efficacy based on reduction of VT episodes during 12 month follow-up
There will be 6 week blanking period after therapy to allow for ablation effect
Time frame: 12 months
Total mortality
Time frame: 12 months
Health related quality of life
Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Time frame: 12 months
Cardiac functional changes
Cardiac functional changes evaluated by echocardiography ejection fraction
Time frame: 12 months
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