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

NCT06696170 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this study

Summary

The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.

Conditions

  • Atrial Fibrillation Paroxysmal
  • Cardiac Ablation
  • Cardiac Arrhythmia

Interventions

DEVICE

CellFX nano-pFA 360 Endocardial Ablation Catheter System

The CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 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 for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) 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 ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Rich A. Nuccitelli, PhD · Pulse Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2026-06-25
Completion
2026-07-25
FDA Device
Yes

Countries

  • Belgium
  • Czechia
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696170 on ClinicalTrials.gov