NCT06703489

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia (VT)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-18
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2024-11-25
• Last updated: 2026-03-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study