Comparing Pulsed Field Ablation Using the VOLT Catheter With Thermal Ablation for Treating Atrial Fibrillation in Adults

What this Trial Is About

Researchers are studying atrial fibrillation AF in adults who are undergoing their first pulmonary vein isolation PVI procedure. The trial compares a new method called pulsed field ablation PFA using the VOLT catheter to conventional thermal ablation techniques, such as radiofrequency or cryotherapy. The goal is to see if PFA is as safe and effective as thermal ablation in preventing irregular heart rhythms and serious complications like cardiac tamponade, stroke, or nerve injury. Participants are randomly assigned to one of two groups. One group will receive PFA with the VOLT catheter, which uses non-thermal pulsed energy delivered by a balloon-in-basket catheter compatible with mapping systems. The other group will receive thermal ablation, either by radiofrequency point-by-point ablation or cryoballoon freezing. Procedures are done under sedation or anesthesia following standard protocols. The study lasts three years, including two years of enrollment and one year of follow-up for each participant. During the study, participants have follow-up visits at 2-3 months, 6 months, and 12 months after the procedure. Heart rhythm is monitored with repeated ECGs, Holter monitors, and weekly home ECG recordings using a Kardia Mobile device in the final three months. Quality of life is assessed using questionnaires at baseline and at 3, 6, and 12 months. Researchers will measure time to arrhythmia recurrence, safety events within 30 days, procedure duration, and other heart function and quality of life outcomes.

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