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

NCT07018596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2026-05-06

No results posted yet for this study

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).

Conditions

  • Atrial Fibrillation Paroxysmal
  • Cardiac Ablation
  • Cardiac Arrhythmia

Interventions

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).

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • David Kenigsberg, MD · Pulse Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2026-10-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • Czechia

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 NCT07018596 on ClinicalTrials.gov