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HRS 2026: Six-Month Outcomes from the Sphere-9 VT Early Feasibility Study

Published: 07 May 2026

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HRS Congress 2026 — In this Arrhythmia Academy expert interview, Brad Wilson, Director of Medical Device Partnerships at Radcliffe and Arrhythmia Academy, speaks with Dr. Pasquale Santangeli (Cleveland Clinic, Ohio, USA) about six-month outcomes from the Sphere-9 VT early feasibility study. 

They review the Affera Sphere-9 lattice tip catheter and mapping-ablation system, a dual-energy, large-footprint (up to 9 mm) platform capable of both radiofrequency (RF) ablation and pulsed field ablation (PFA), designed to deliver efficient, high-quality lesion creation and true “map-and-ablate” workflows in scar-related ventricular tachycardia.

Dr. Santangeli outlines the rationale for using this technology in ischemic VT—addressing historical limitations of lesion depth, small 4 mm footprints, and high-flow RF irrigation in heart failure patients—and describes the multicenter early feasibility study across five high-volume centers. In the initial 40-patient, purely ischemic cardiomyopathy cohort (predominantly endocardial ablation), the study achieved 100% acute VT non-inducibility and approximately 66% VT-free survival at six months in a very sick, large-substrate population, with no major safety signal aside from a single RF-related phrenic nerve paralysis in a thin aneurysm. The discussion highlights how Sphere-9 is currently used for the most challenging substrates, its potential evolution into a workhorse catheter for broader structural heart disease populations, and the planned Medtronic-sponsored pivotal study to validate performance across a wider range of centers.

Recorded on-site at HRS Congress 2026, Chicago.

Editor: Jordan Rance
Videographer: Oliver Miles

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