NCT07018596

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

Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).

Detailed description

This study is a prospective, multicenter, non-randomized clinical investigation. Eligible participants with drug-resistant paroxysmal AF who are clinically indicated for a cardiac catheter ablation procedure will undergo nsPFA ablation with the CellFX Cardiac Catheter Ablation System. The primary endpoints will be assessed at 6 months after the ablation procedure.

Conditions

• Atrial Fibrillation Paroxysmal
• Cardiac Ablation
• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	CellFX nsPFA Cardiac Catheter System	The CellFX nsPFA Cardiac 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).

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2025-06-12
• Last updated: 2025-12-24

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study