Real-World Study of the Volt Pulsed Field Ablation System for Treating Paroxysmal and Persistent Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the Volt PFA System in people with paroxysmal and persistent atrial fibrillation who have symptoms and have not responded to drug treatment. The study aims to gather real-world evidence on the safety and effectiveness of this balloon-based pulsed field ablation device, with additional clinical information gathered in a sub study focused on electrophysiology. Participants will undergo a new ablation procedure using the Volt PFA Catheter to treat their atrial fibrillation. This interventional study involves applying pulsed field ablation with the Volt PFA System to target the affected heart tissue. The procedure is performed once, and patients will be monitored for outcomes related to the device and treatment. Throughout the study, participants will be observed for serious adverse events within 7 days after the ablation procedure. Effectiveness will be measured by the absence of atrial fibrillation, atrial flutter, or atrial tachycardia recurrence over 12 months. Also, acute procedural success is confirmed during the procedure by checking electrical block in all targeted pulmonary veins. Participants must comply with follow-up testing and visits throughout the study period ending in 2027.

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF