Evaluating Safety and Effectiveness of the Sphere-9 Catheter and Affera System for Treating Ventricular Tachycardia in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the Sphere-9 Catheter combined with the Affera Mapping and Ablation System for treating adults with recurrent, sustained, scar-related monomorphic ventricular tachycardia. This prospective, multi-center, non-randomized, unblinded study focuses on patients who have had a history of ventricular tachycardia that continues despite medication or implantable cardiac defibrillator ICD intervention. Participants will undergo ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System. This procedure is studied as a treatment to address the ventricular tachycardia. The study observes the effects of the ablation procedure on the day of treatment and follows up on safety within 7 days, as well as chronic effectiveness up to 6 months after the procedure. During the study, participants will be monitored closely with assessments focusing on procedural safety and success. These include evaluations on the day of ablation, safety checks within 7 days post-procedure, and longer-term effectiveness assessments within 6 months. Participants must comply with testing requirements before, during, and after the procedure for comprehensive monitoring throughout the study period.

Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)