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The Lead Episode 105: 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)
Description
Michael S. Lloyd, MD, FHRS, Emory University is joined by Edward P. Gerstenfeld, MD, MS, FHRS, University of California, San Francisco, and Christopher C Cheung, MD, MPH, FHRS, Sunnybrook HSC, University of Toronto, to discuss the VOLT-AF IDE study evaluated the safety and effectiveness of a novel balloon-based pulsed field ablation (PFA) catheter system for treating paroxysmal and persistent atrial fibrillation (PAF and PsAF). Conducted at 34 global sites, the study enrolled 394 subjects, with 320 included in the primary analysis. Acute pulmonary vein isolation (PVI) success was achieved in over 99% of veins, and primary serious adverse events occurred in only 1.9% of patients, with no significant complications like esophageal injury or hemolysis. Procedure metrics showed efficient operation times, and early 6-month data suggest promising effectiveness. These initial findings support the Volt™ PFA system as a safe and effective treatment option for AF. 
Learning Objectives
  • Evaluate the safety and effectiveness of balloon-based PFA catheters in paroxysmal and persistent atrial fibrillation.
Article Authors and Podcast Contributors
Article Authors

Monica Y. Lo Alok Gambhir Sri Sundaram Prashanthan Sanders David B. De Lurgio Stavros Mountantonakis Christopher Woods Petr Neuzil Joaquin Osca Amar Trivedi Peter Loh Hugh Calkins David A. Strouse Atul Verma Gian B. Chierchia Brett D. Atwater Dhanunjaya R. Lakkireddy

Podcast Contributors

Michael S. Lloyd, MD, FHRS, Emory University
Edward P. Gerstenfeld, MD, MS, FHRS, University of California, San Francisco
Christopher C Cheung, MD, MPH, FHRS, Sunnybrook HSC, University of Toronto

Faculty and Disclosures
All relevant financial relationships have been mitigated.

Host Disclosure(s):

M. Lloyd:
Honoraria/Speaking/Consulting: Medtronic, Arga Medtech, Circa Scientific
Membership on Advisory Committees: Boston Scientific

Contributor Disclosure(s):

E. Gerstenfeld
:
Honoraria/Speaking/Consulting: Medtronic, Boston Scientific, Biosense Webster, Abbott, Varian Medical Systems, Biotronik
Other Non-Financial Relationships: Farapulse, Adagio Medical, Boston Scientific, Abbott Medical
Research (Contracted Grants for PIs and Named Investigators only): Abbott Medical
Officer, Trustee, Director, Committee Chair, or Any Other Fiduciary Role: American College of Cardiology Foundation

C. Cheung
:
Nothing to disclose.
 

Staff Disclosure(s) (note: HRS staff are NOT in control of educational content. Disclosures are provided solely for full transparency to the learner):
S. Sailor: No relevant financial relationships with ineligible companies to disclose.
S. Colbert: No relevant financial relationships with ineligible companies to disclose.
Summary
Availability: On-Demand
Cost: FREE
Credit Offered:
No Credit Offered
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