Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation

The goal of this clinical trial is to evaluate whether pulsed field ablation (PFA) using the novel VOLT catheter is as safe and effective as conventional thermal ablation (radiofrequency or cryotherapy) for the treatment of atrial fibrillation (AF) in adult patients undergoing their first pulmonary vein isolation (PVI). The main questions it aims to answer are: * Is PFA with the VOLT catheter non-inferior to thermal ablation in preventing recurrence of atrial tachyarrhythmias 2-12 months after the procedure? * Is PFA with the VOLT catheter associated with fewer or comparable serious complications (such as cardiac tamponade, stroke, or phrenic nerve injury)? Researchers will compare the outcomes between patients receiving PFA with the VOLT catheter and those treated with thermal ablation techniques to see if PFA offers comparable or potentially better safety and efficacy. Participants will: * Be randomly assigned (1:1) to receive either pulsed field ablation (PFA) or thermal ablation (radiofrequency or cryotherapy). * Undergo standard follow-up visits at 2-3 months, 6 months, and 12 months post-ablation. * Have repeated ECGs and Holter monitoring to assess heart rhythm. * Complete quality of life questionnaires at baseline, 3, 6, and 12 months. * Use a home ECG device (Kardia Mobile) weekly during the final 3 months of the study. The study includes 136 adults (≥18 years) with paroxysmal or persistent AF, in two participating hospitals. The total study duration is 3 years, including a 2-year enrollment period and 1-year follow-up per participant.

NCT Number	NCT07156877
Lead Sponsor	Sebastien Knecht
Conditions	Atrial Fibrillation (AF)
Enrollment	136 participants
Start Date	2025-12-05
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-12