Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Prior myocardial infarction (MI).
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.
Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure.
Incessant VT necessitating hemodynamic support prior to the ablation procedure.
Unstable polymorphic VT or ventricular fibrillation (VF).
Idiopathic VT or VT of non-ischemic cardiomyopathy.
VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
Single group
Sphere-9 Catheter with the Affera Mapping and Ablation System
DeviceAdult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.
Primary Safety
A pre-defined list of device- or procedure-related SAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event.
Primary Effectiveness
Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) through 6 months after the index ablation procedure.
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