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

NCT06696170 | Recruiting FDA Device

• 1 other identifier: NP-CCF-033
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

nsPFA; CellFX; Pulsed Field Ablation; nano-PFA

Outcome Measures

Primary Outcomes (2)

• Rate of primary safety major adverse events (MAEs)

  The primary safety endpoint includes major adverse events (MAEs) specifically related to the device or ablation procedure for the following * Asymptomatic Cerebral Embolism * Arterioesophageal Fistula * Bleeding Requiring Transfusion * Cardiac Perforation/Tamponade * Death * Esophageal Injury Resulting in Perforation * Myocardial Infarction * Pericarditis Requiring Intervention or Hospitalization * Phrenic Nerve Injury/Diaphragmatic Paralysis * Pulmonary Edema/Respiratory Insufficiency * Pulmonary Vein Stenosis (≥70% diameter reduction) * Stroke or Transient Ischemic Attack * Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis * Vascular Access Complication Requiring Intervention

  Within 30 days post-ablation procedure

• Proportion of participants achieving acute procedural success.

  Acute procedural success is achieving entrance block of the pulmonary veins

  Immediately post-ablation procedure

Secondary Outcomes (3)

• Proportion of participants reporting one or more significant adverse events (SAEs)

  Within 12 months post-ablation procedure

• Proportion of participants achieving long-term technical success

  Within 3 months post-ablation procedure

• Proportion of participants achieving treatment success

  Within 12 months post-ablation procedure

Study Arms (1)

CellFX nano-PFA Treatment Arm

EXPERIMENTAL

CellFX nano-PFA 360 Endocardial Ablation Catheter System

Device: CellFX nano-pFA 360 Endocardial Ablation Catheter System

Interventions

CellFX nano-pFA 360 Endocardial Ablation Catheter System DEVICE

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).

CellFX nano-PFA Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment
• Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study
• Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
• Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents
• Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure
• Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators

You may not qualify if:

• Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
• Subject has a prosthetic heart valve
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• AF episodes lasting \> 7 days
• Previous ablation for AF
• Subjects on amiodarone at any time during the past 3 months prior to enrollment
• Prior history of pericarditis or pericarditis within 3 months based on the TTE examination
• Prior history of rheumatic fever
• Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion)
• History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
• History of abnormal bleeding and/or clotting disorder
• Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as Warfarin)
• Active malignancy or history of treated cancer within 24 months of enrollment
• Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (3)

Hartcentrum Hasselt Research Center /Jessa Hospital

Hasselt, Belgium

ACTIVE NOT RECRUITING

Na Homolce Hospital

Prague, Czechia

RECRUITING

Policlinico Tor Vergata Hospital

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rich A. Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY DIRECTOR

Central Study Contacts

William A. Knape

CONTACT

510-906-4649; bknape@pulsebiosciences.com

Aleksandra Kurek

CONTACT

+44 745 6655949; aleksandra.kurek@pulsebiosciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CZ (1); IT (1)