RecruitingNot ApplicableNCT06696170

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

Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation

Sponsor

Pulse Biosciences, Inc.

Enrollment

60 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (Paroxysmal)Cardiac Arrhythmia Cardiac Ablation

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and effectiveness of the CellFX PFA 360 catheter — a device that uses nanosecond pulsed field ablation (a precise, non-heat-based electrical energy) — to treat paroxysmal atrial fibrillation (AF), a type of irregular heartbeat that comes and goes. The procedure targets the electrical pathways in the heart that trigger these episodes. **You may be eligible if...** - You are between 18 and 75 years old - You have paroxysmal atrial fibrillation (episodes that start and stop on their own), with at least one episode documented by a heart tracing in the past year - You have tried at least one anti-arrhythmic medication and it has not worked, or you could not tolerate the medication - Your heart is not severely enlarged and your heart pumping function is at least 40% - Your doctor has determined you are a suitable candidate for an investigational heart procedure **You may NOT be eligible if...** - You have a pacemaker, implantable defibrillator, or cardiac resynchronization device - You have a prosthetic heart valve - Your AF is caused by an underlying reversible condition (such as thyroid disease or electrolyte imbalance) - Your AF episodes last longer than 7 days at a time - You have had a previous ablation procedure for AF Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECellFX 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).