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RECRUITING
NCT07585968
NA

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

Sponsor: Medtronic Cardiac Ablation Solutions

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-08-17

Completion Date

2028-09

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DEVICE

Sphere-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 (7)

South Denver Cardiology Associates

Littleton, Colorado, United States

Ascension Saint Vincent Hospital - Indianapolis

Indianapolis, Indiana, United States

Northwell Health Lenox Hill Hospital

Manhasset, New York, United States

NYU Langone Medical Center

New York, New York, United States

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