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RECRUITING
NCT06703489
NA

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

Sponsor: Medtronic Cardiac Ablation Solutions

View on ClinicalTrials.gov

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.

Official title: Safety and Performance Assessment 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

60

Start Date

2025-03-18

Completion Date

2027-01

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DEVICE

Sphere-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.

Locations (6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States