Stereotactic Radioablation for Ventricular Tachycardia Clinical Trial
Official title:
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. ;