STAR VTM

STereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management

In this single centre, single arm pilot study, we will test whether STAR, performed using available cardiac imaging, prior mapping/electrogram information, and standard ECGs, but without a multi-electrode ECG vest for noninvasive pre-procedural mapping, has an acceptable safety profile in patients with cardiomyopathy and monomorphic VT that has been refractory to conventional antiarrhythmic management. We will also obtain preliminary data on the effectiveness of this therapy in reducing VT burden, in order to plan for a future multi-center clinical trial.

Enrolment Criteria

Inclusion

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):
- Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy,
- ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic,
- ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms,
- ≥1 appropriate ICD shocks,
- ≥3 monomorphic VT episodes within 24 hours
VT events must be confirmed by ECG/monitor or ICD download.
Exclusion
- 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