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.
https://www.hrsonline.org/education/TheLead
https://www.heartrhythmjournal.com/article/S1547-5271(25)02168-X/fulltext
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.
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