375
Participants
Start Date
August 25, 2025
Primary Completion Date
October 25, 2026
Study Completion Date
January 25, 2027
CellFX nsPFA Endocardial Ablation Catheter System
The CellFX nsPFA Endocardial Ablation Catheter System includes the nsPFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures to treat arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nanosecond pulses of electrical energy. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the cell's and internal organelles' ability to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
Clinic Electrophysiology, Heart Center Hasselt, Jessa Hospital, Hasselt
Na Homolce Hospital, Prague
Pulse Biosciences, Inc.
INDUSTRY