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

Name: Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) — clinical trial record (NCT06703489)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhaseNot applicable

SponsorMedtronic Cardiac Ablation Solutions

Started2025-03-18

View on ClinicalTrials.gov ↗

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.

Amendment history 2 changes detected by DataLookout

2026-09-04

Primary completion pushed: 2026-07 → 2026-11

2026-09-04

Completion pushed: 2027-01 → 2027-05

Trial Details

NCT Number	NCT06703489
Lead Sponsor	Medtronic Cardiac Ablation Solutions
Conditions	Ventricular Tachycardia (VT)
Enrollment	60 participants
Start Date	2025-03-18
Primary Completion	2026-11 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-09-03