Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Study Overview
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Brief Summary
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Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.

Official Title
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Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Radiation: Stereotactic Body Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients with structural heart disease Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D) Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect). Persistent recurrence of VT despite adequate pharmacotherapy. Informed consent of the patient to participate in the study. Exclusion Criteria: Premature ventricular contractions Cardiac damage requiring inotropic treatment Implantation of left ventricular assist device (LVAD) Ventricular arrhythmia in the course of channelopathy Reversible cause of VT New York Heart Association (NYHA) stage IV heart failure Myocardial infarction or cardiac surgery in the last 3 months. Life expectancy less than 6 months Polymorphic ventricular tachycardia Pregnancy or breastfeeding Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments). Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study. Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation. Lack of the informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Cardiac radioablation<br>Patients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping. | Radiation: Stereotactic Body Radiotherapy<br>* Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)<br>* Other names: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the treatment | Number of patients with a reduction of the number of ventricular tachycardia (VT) episodes by at least 50% within 6 months after the irradiation compared to the number of VT episodes within 6 months before the intervention (based on registration from ICD/CRT-D), including: the number of high-energy discharges number of low-energy discharges for VT that was treated with stereotactic radiotherapy (STAR) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-month survival without VT episodes |  | 6 months | 
| Number of patients with complete elimination of ICD discharges |  | 12 months | 
| Number of patients with a 90% reduction in the number of ICD discharges |  | 12 months | 
| Number of hospitalizations due to VT episodes |  | 12 months | 
| Recurrences outside the irradiated area | Number of patients who developed VT with a different morphology than specified during qualification for the procedure | 12 months | 
| Early treatment safety | Number of serious adverse events (SAE) in the first 3 months after the intervention | 3 months | 
| Long term treatment safety | Number of SAE episodes within 12 months after the intervention | 12 months | 
| Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage. | Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and | 12 months | 
| Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up |  | 12 months | 
| Change in the need for antiarrhythmic drugs |  | 12 months | 
| Evaluation of changes in the left ventricular ejection fraction |  | 12 months | 
| Evaluation of changes in the morphology of the heart in the ultrasound examination |  | 12 months | 
| Assessment of compliance of the results of additional imaging with the results of EAM | Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radioablation, stereotactic arrhythmia radioablation (STAR), stereotactic body radiotherapy (SBRT), ventricular tachycardia