Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

Study Overview
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Brief Summary
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Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia. STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.

Detailed Description
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Study Hypotheses: Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia. STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest. Study Objectives: Evaluate the safety of STAR in a local cohort Estimate effectiveness of STAR in reducing VT burden Study Design: Prospective single center, single arm, non-randomized trial. Number of patients: 20 patients Study Duration: Enrollment will occur over three years and at least minimum follow up of six months Study Population: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management. Primary safety endpoint: Any treatment-related serious adverse events in the first 90 days. Primary efficacy endpoint: Reduction in VT episodes tracked by ICD with a six week blanking period. Statistical methodology: Wilcoxon matched-pairs signed-ranks test to compare the number of treated episodes before and after. Assessment of events: Adjudicated by study investigators Economic Analysis: Costs and resources required for STAR .Compare costs between the patients undergoing STAR with conventional catheter-based VT ablation.

Official Title
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Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

Conditions
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Stereotactic Radioablation for Ventricular Tachycardia

Intervention / Treatment
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* Radiation: Stereotactic Radioablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and have an implanted cardioverter defibrillator (ICD) with: Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download. Exclusion Criteria: Has received prior radiotherapy to the anticipated treatment field Pregnancy Unable to unwilling to provide informed consent New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia. Active coronary ischemia in the last 30 days.

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
Interventional Model Description: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radioablation Treatment<br>Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia | Radiation: Stereotactic Radioablation<br>* External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of radiation treatment for VT reduction | Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment. | 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment. | 
| Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function. | Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction. | 90 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Six month survival after treatment | Six months |