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

May 3, 2026 updated by: Pulse Biosciences, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, non-randomized, open labelled, single-arm first-in-human (FIH) feasibility study to evaluate the initial clinical safety and device performance of the nano-PFA 360 Catheter Endocardial Ablation System for the treatment of atrial fibrillation. Enrolled subjects will be followed for up to 12 months post-nano PFA 360 Catheter Ablation. All subjects will undergo an electroanatomical mapping procedure post-ablation to evaluate immediate pulmonary vein isolation (PVI) and at 3 months post-index procedure to assess electrical isolation of the pulmonary veins.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Active, not recruiting
        • Hartcentrum Hasselt Research Center /Jessa Hospital
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Na Homolce Hospital
        • Contact:
          • Štěpán Královec
        • Principal Investigator:
          • Prof. Petr Neuzil, MD, PhD
  • Italy
      • Roma, Italy
        • Recruiting
        • Policlinico Tor Vergata Hospital
        • Contact:
          • Giuseppe Stifano, MD, PhD
        • Principal Investigator:
          • Prof. Andrea Natale, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • New York Heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment
  • Body mass index > 35 kg/m2
  • Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has ever received hemodialysis
  • History of untreated and serious hypotension, bradycardia or chronotropic incompetence

  • Any of the following within 3 months of enrollment:

    1. Major surgery except for the index procedure
    2. Myocardial infarction
    3. Unstable angina
    4. Percutaneous coronary intervention
    5. Sudden cardiac death event
    6. Left atrial thrombus that has not resolved as shown by TEE or CT
  • Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
  • History of pulmonary hypertension with pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
  • Subjects with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)
  • Life expectancy less than one year
  • Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
  • Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period
  • Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CellFX nano-PFA Treatment Arm
CellFX nano-PFA 360 Endocardial Ablation Catheter System
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of primary safety major adverse events (MAEs)
Time Frame: Within 30 days post-ablation procedure

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.
Time Frame: Immediately post-ablation procedure
Acute procedural success is achieving entrance block of the pulmonary veins
Immediately post-ablation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving long-term technical success
Time Frame: Within 3 months post-ablation procedure
Long-term technical success is defined as electrical isolation of the pulmonary veins (PVI) assessed during an electroanatomical mapping procedure.
Within 3 months post-ablation procedure
Proportion of participants reporting one or more significant adverse events (SAEs)
Time Frame: Within 12 months post-ablation procedure

Safety related to the reporting one or more SAEs for each follow-up interval as described.

  • Atrio-esophageal fistula (up to 3-month visit)
  • Pulmonary Vein (PV) stenosis (up to 3-month visit)
  • Subjects presenting with Primary SAEs up to the 12-month post- procedure follow-up
  • Subjects presenting with any AEs or SAEs up to the 12-month post- procedure follow-up
Within 12 months post-ablation procedure
Proportion of participants achieving treatment success
Time Frame: Within 12 months post-ablation procedure

Treatment success is defined by freedom from the following failures:

  1. Recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 secs on transtelephonic monitoring (TTM), Holter monitoring, or continuously 12-lead electrocardiogram (ECG)
  2. Cardioversion for atrial fibrillation (AF) /atrial flutter (AFL) / atrial tachycardia (AT)
  3. Repeat ablation failure
  4. Antiarrhythmic Drugs (AADs) failure
  5. Surgical treatment for AF/AFL/AT after the index procedure
Within 12 months post-ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulse Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rich A. Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP-CCF-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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