Evaluating Safety and Effectiveness of the CellFX Nano-PFA 360 Catheter System for Treating Atrial Fibrillation in Adults

What this Trial Is About

Researchers are evaluating the initial safety and performance of the CellFX nano-second Pulsed Field Ablation nsPFA 360 Catheter Endocardial Ablation System for treating atrial fibrillation. This first-in-human, prospective, non-randomized, open-label study aims to assess how well this device works and its safety in patients with paroxysmal atrial fibrillation who have not responded to certain medications. The study is sponsored by Pulse Biosciences, Inc. and focuses on cardiac arrhythmia treatment using a novel ablation technology. The study involves using the CellFX nano-PFA 360 Catheter System, which delivers nanosecond electrical pulses to heart tissue to disrupt abnormal electrical signals causing atrial fibrillation. Subjects will receive the ablation treatment during a cardiac electrophysiology procedure, followed by immediate and 3-month assessments to check the electrical isolation of the pulmonary veins. The system includes the catheter, console, and related accessories designed for this purpose. This is a single treatment arm study without randomization or placebo. Participants will be monitored for up to 12 months after the procedure. They will undergo electroanatomical mapping immediately after ablation and again at 3 months to evaluate treatment success. Researchers will track safety outcomes including major adverse events within 30 days, as well as longer-term adverse events and treatment effectiveness over 12 months. Follow-up visits include clinical examinations and tests to assess heart function and arrhythmia recurrence, ensuring comprehensive monitoring of both safety and device performance.

CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation