RecruitingNot ApplicableNCT07585968

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

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


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

260 participants

Start Date

Aug 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


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. The study is currently recruiting participants at 2 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 ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.


Locations(3)

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07585968


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