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
Single group
Sphere-9 Catheter with the Affera Mapping and Ablation System
DeviceAdult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.
Primary Safety Endpoint: evaluate the safety of the index ablation procedure
Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events
Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
Percentage of patients whose targeted clinically relevant monomorphic ventricular tachycardia cannot be induced
Secondary Endpoint: assess chronic effectiveness of the index ablation procedure
Percentage of patients free from recurrence of sustained monomorphic ventricular tachycardia
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