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

NCT07018596 | Recruiting DMC FDA Device

• 1 other identifier: NP-CCP-US-043
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nsPFA; Pulsed Field Ablation; nano-PFA

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with freedom from primary safety endpoint

  The primary safety endpoint is freedom from a primary safety endpoint for the following: * Cerebrovascular accident/Stroke * Thromboembolism * Myocardial infarction * Severe Pericarditis (requiring intervention) * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Major vascular access complications * Bleeding * Pulmonary edema * Heart Block * Permanent Phrenic Nerve paralysis * Device or Procedure-related Death * CellFX System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours, excluding recurrent atrial fibrillation/atrial flutter/atrial tachycardia (AF/AFL/AT) * Cardiac tamponade/perforation * Significant acute kidney injury secondary to hemolysis * Pulmonary vein stenosis * Esophageal perforating complications

  Within 7 days, 30 days, and 6 months post-ablation procedure

• Proportion of participants achieving freedom from treatment failure.

  Acute procedural failure is defined as the inability to isolate all targeted pulmonary veins (PV) (minimally assessed for entrance block and, where assessable, exit block) during the index procedure or PV ablation using a non-study device in the left atrium

  6 months post-ablation

Secondary Outcomes (1)

• Proportion of participants achieving acute procedural success

  Immediately post-ablation procedure

Study Arms (1)

nsPFA Cardiac Catheter System Treatment Arm

EXPERIMENTAL

Nanosecond Pulsed Field Ablation (nsPFA) technology will be used for ablating cardiac tissue using the CellFX nsPFA Cardiac Catheter System

Device: CellFX nsPFA Cardiac Catheter System

Interventions

CellFX nsPFA Cardiac Catheter System DEVICE

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).

nsPFA Cardiac Catheter System Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
• i. Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment
• Age 18 through 85 years old (or older than 18 if required by local law)
• Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.
• Participant is willing and capable of providing Informed Consent
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators

You may not qualify if:

• Left atrial diameter ≥5.5 cm (anteroposterior)
• Any of the following within 3 months prior to enrollment:
• Any cardiac surgery
• Myocardial infarction
• Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
• Unstable angina
• Pericarditis or symptomatic pericardial effusion
• Any of the following within 6 months prior to enrollment:
• Any cerebral ischemic event (stroke or transient ischemic attack (TIA)
• History of thromboembolic event
• Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)
• Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.
• Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (1)

Na Homolce Hospital

Prague, Roentgenova, 37/2, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• David Kenigsberg, MD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Central Study Contacts

Micki Weisman

CONTACT

510-906-4649; micki.weisman@pulsebiosciences.com

William A. Knape

CONTACT

510-906-4649; bknape@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: June 5, 2025
• First Posted: June 12, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)