Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
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 Hypotheses:

 1. Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for
 cardiomyopathy patients for management of refractory ventricular tachycardia.

 2. STAR can be performed with available cardiac imaging, prior mapping/electrogram
 information, and standard ECGs without a multi-electrode ECG vest.

 Study Objectives:

 1. Evaluate the safety of STAR in a local cohort

 2. 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.
Inclusion Criteria:

 18 years of age and have an implanted cardioverter defibrillator (ICD) with:

 1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with
 cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of
 scar.

 2. 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.