Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
At least one episode of sustained (continuous for >30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.
Incessant VT necessitating hemodynamic support prior to the ablation procedure.
Unstable polymorphic VT or ventricular fibrillation (VF).
Idiopathic VT
Automaticity or triggered activity
Medtronic Cardiac Ablation Solutions
Lead sponsor