NS-PFA Catheter Ablation of Paroxysmal and Persistent Atrial Fibrillation With the Pulse Biosciences CellFX System

NANot yet recruitingINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

August 25, 2025

Primary Completion Date

October 25, 2026

Study Completion Date

January 25, 2027

Conditions
Atrial Fibrillation ParoxysmalCardiac AblationCardiac ArrhythmiaAtrial Fibrillation, Persistent
Interventions
DEVICE

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).

Trial Locations (2)

Unknown

Clinic Electrophysiology, Heart Center Hasselt, Jessa Hospital, Hasselt

37/2

Na Homolce Hospital, Prague

All Listed Sponsors
lead

Pulse Biosciences, Inc.

INDUSTRY