Clinical trial NCT07018596: NS-PFA Catheter Ablation of Paroxysmal and Persistent Atrial Fibrillation With the Pulse Biosciences CellFX System
Official title: Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Cardiac Ablation
Cardiac Arrhythmia
Atrial Fibrillation, Persistent
Keywords: nsPFA
Pulsed Field Ablation
nano-PFA
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Catheter Endocardial Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal and persistent atrial fibrillation (AF).

Detailed description: This study is a prospective, multicenter, two-cohort, non-randomized clinical investigation. Eligible participants with drug-resistant paroxysmal or persistent AF who are clinically indicated for an endocardial cardiac ablation procedure will undergo nsPFA ablation with the CellFX Catheter Endocardial Ablation System. The primary endpoints will be assessed at 6 months after the ablation procedure. The paroxysmal AF cohort and the persistent AF cohort will be assessed independently for success.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of recurrent drug-resistant (Class I - IV) symptomatic paroxysmal or persistent AF:

   a. Symptomatic paroxysmal AF is defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:

   i. Physician's note indicating recurrent self-terminating AF prior to enrollment; AND

   ii. At least one (1) ECG documented AF episode from any form of rhythm monitoring within six (6) months prior to enrollment

   OR

   b. Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:

   i. physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment;

   AND either

   iia. any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR

   iib. Two (2) ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment.
   * Age 18 through 85 years old (or older than 18 if required by local law)
   * 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

   Exclusion Criteria:
   * Left atrial diameter ≥5.5 cm (anteroposterior)
   * Any of the following within 3 months prior to enrollment:

     1. Any cardiac surgery
     2. Myocardial infarction
     3. Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
     4. Unstable angina
     5. Pericarditis or symptomatic pericardial effusion
   * Any of the following within 6 months prior to enrollment:

     1. Any cerebral ischemic event (stroke or transient ischemic attack (TIA)
     2. 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).
   * Prior diagnosis of pulmonary vein stenosis
   * Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
   * Moderate to severe mitral valve stenosis
   * More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
   * New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)
   * History of pulmonary hypertension with pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
   * Rheumatic heart disease
   * Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
   * Active systemic infection
   * Hypertrophic cardiomyopathy
   * Atrial myxoma
   * Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
   * History of abnormal bleeding and/or clotting disorder
   * Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
   * History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
   * Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
   * Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
   * Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
   * Body Mass Index (BMI) \> 40.0
   * Participants 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
   * Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor
   * Unwilling or unable to comply fully with study procedures and follow-up

Primary outcomes:
measure: Proportion of participants with freedom from primary safety endpoint
timeFrame: Within 7 days, 30 days, and 6 months post-ablation procedure
measure: Proportion of participants achieving freedom from treatment failure.
timeFrame: 6 months post-ablation
Secondary outcomes:
measure: Proportion of participants achieving acute procedural success
timeFrame: Immediately post-ablation procedure
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Clinic Electrophysiology, Heart Center Hasselt, Jessa Hospital
city: Prague
country: Czechia
facility: Na Homolce Hospital
state: Roentgenova
Study officials:
affiliation: Pulse Biosciences, Inc.
name: David Kenigsberg, MD
role: STUDY_CHAIR
References: