STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Study Overview
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Brief Summary
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Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.

Detailed Description
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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.

Official Title
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STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Conditions
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Refractory Ventricular Tachycardia

Intervention / Treatment
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* Procedure: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICD/S-ICD recipients with refractory VT Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia. LVEF ≥ 20%. Age ≥ 50 years. Signed an IRB approved written informed consent document. Exclusion Criteria: Previous radiotherapy with cardiac involvement. Pregnancy or breastfeeding. Active myocardial ischemia. Acute revascularation in the past 120 days. Acute hemodynamic instability (cardiogenic shock/NYHA IV). Serious disease with presumed life expectancy less than 12 months. Any condition that is deemed a contraindication in the judgment of the investigators.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT. | Procedure: SBRT<br>* Multimodal-imaging guided SBRT for VT ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBRT safety during 12 month follow-up | Serious adverse events will be defined using CTCAE v4.0 criteria. | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality |  | 12 months | 
| Health related quality of life | Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire | 12 months | 
| Cardiac functional changes | Cardiac functional changes evaluated by echocardiography ejection fraction | 12 months |