Stereotactic Non-invasive Ablation of Ventricular Tachycardia

Study Overview
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Brief Summary
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STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).

Detailed Description
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The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).

Official Title
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STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Procedure: 4-D navigated stereotactic radio surgical ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease) Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator) Prior ≥1 catheter ablation procedure for monomorphic VT VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated) Age ≥30 years Signed an IRB-approved (Institutional Review Board) written informed consent Exclusion Criteria: Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months) Primary electrical disease (channelopathy) Reversible cause of VT (e.g. drug-induced, intoxications, etc) Pregnancy or breastfeeding Chronic heart failure New York Heart Association (NYHA) Class IV Serious comorbidities with presumed life expectancy less than one year Significant peripheral artery disease precluding retrograde aortic mapping History of chest radiotherapy

Ages Eligible for Study
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Minimum Age: 30 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: 4-D navigated stereotactic radiosurgical ablation<br>Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation | Procedure: 4-D navigated stereotactic radio surgical ablation<br>* 4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sustained VT burden in three 3-month intervals | Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable. | 50 months | 
| Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold | All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable. | 50 months | 
| 3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0. | The rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed. | 53 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all-cause death and appropriate ICD shock | The composite endpoint of all-cause death and appropriate ICD shock will be observed for the period of up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable. | 50 months | 
| Electric storm recurrence | The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable. | 53 months | 
| Cardiovascular hospitalisations | The hospitalisations due to cardiovascular indications will be observed. | 53 months | 
| Change in quality of life | Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life. | 53 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Structural Heart Disease, Ventricular Tachycardia, Substrate Ablation, Stereotactic Radiosurgery, Functional Radiosurgery, 4D navigation