The Lead Episode 106: A Discussion of Acute Safety and Effectiveness of a Novel Balloon-Based PFA Catheter in Paroxysmal and Persistent AF: Acute Results of the Volt-AF IDE Trial (Live at HRS 2025)

Discussion Topic: First-in-human study of a leadless pacemaker system for left bundle branch area pacing

Prashanthan Sanders, MBBS, PhD, FHRS, University of Adelaide is joined by Jenish Shroff, MBBS, MD, Australian National University, and Pugazhendhi Vijayaraman, MD, FHRS, Geisinger Heart Institute, to discuss this first-in-human feasibility study evaluated a novel helix-based leadless pacemaker (LPCSP) designed to achieve left bundle branch area pacing (LBBAP), a capability current LPs lack. The device was temporarily implanted via the internal jugular vein into the interventricular septum in 14 patients, with successful implantation in 10. Electrical performance metrics, including pacing threshold, R-wave amplitude, and impedance, were within acceptable clinical ranges. LBBAP capture was achieved in 5 patients, with no serious device-related adverse events in 85.7% of cases. The study supports the acute safety and feasibility of LPCSP for conduction system pacing.

Host: Prashanthan Sanders, MBBS, PhD, FHRS
Guests:  Jenish Shroff, MBBS, MD and Pugazhendhi Vijayaraman, MD, FHRS

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