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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Ventricular Tachycardia (VT)
Interventions
DEVICE

Sphere-9 Catheter with the Affera Mapping and Ablation System

Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due to prior myocardial infarction will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.

Trial Locations (5)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

44195

ACTIVE_NOT_RECRUITING

Cleveland Clinic Foundation, Cleveland

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
lead

Medtronic Cardiac Ablation Solutions

INDUSTRY

NCT06703489 - Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | Biotech Hunter | Biotech Hunter