RecruitingNot ApplicableNCT06703489

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

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

Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

60 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Ventricular Tachycardia (VT)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sphere-9 Catheter with the Affera Mapping and Ablation System for people with ventricular tachycardia (vt). The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESphere-9 Catheter with the Affera Mapping and Ablation System

Adult 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.