Actively Recruiting
Initial Safety and Performance of the CellFX Nano-PFA 360 Catheter Endocardial Ablation System for Treatment of Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-05-05
60
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the initial safety and performance of the CellFX nano-second Pulsed Field Ablation (nsPFA) 360 Catheter Endocardial Ablation System for treating atrial fibrillation. This first-in-human, prospective, non-randomized, open-label study aims to assess how well this device works and its safety in patients with paroxysmal atrial fibrillation who have not responded to certain medications. The study is sponsored by Pulse Biosciences, Inc. and focuses on cardiac arrhythmia treatment using a novel ablation technology. The study involves using the CellFX nano-PFA 360 Catheter System, which delivers nanosecond electrical pulses to heart tissue to disrupt abnormal electrical signals causing atrial fibrillation. Subjects will receive the ablation treatment during a cardiac electrophysiology procedure, followed by immediate and 3-month assessments to check the electrical isolation of the pulmonary veins. The system includes the catheter, console, and related accessories designed for this purpose. This is a single treatment arm study without randomization or placebo. Participants will be monitored for up to 12 months after the procedure. They will undergo electroanatomical mapping immediately after ablation and again at 3 months to evaluate treatment success. Researchers will track safety outcomes including major adverse events within 30 days, as well as longer-term adverse events and treatment effectiveness over 12 months. Follow-up visits include clinical examinations and tests to assess heart function and arrhythmia recurrence, ensuring comprehensive monitoring of both safety and device performance.
CONDITIONS
Brief Title
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years on the day of enrollment
- Able and willing to provide informed consent and participate in all study procedures and follow-up visits
- Diagnosed with paroxysmal atrial fibrillation with at least one documented episode within the past year
- Failed at least one antiarrhythmic drug or AV nodal blocking agent due to recurrent symptoms or intolerance
- Left atrial diameter less than or equal to 5.5 cm as shown by recent heart imaging
- Left ventricular ejection fraction of 40% or higher based on recent echocardiography
- Completed standard cardiac evaluation and deemed appropriate for investigational procedure by investigators
You will not qualify if you...
- Presence of implantable electronic devices such as pacemakers or defibrillators or left atrial appendage devices
- Having a prosthetic heart valve
- Atrial fibrillation caused by electrolyte imbalance, thyroid issues, or other non-cardiac reversible causes
- Atrial fibrillation episodes lasting longer than 7 days
- Previous ablation treatment for atrial fibrillation
- Use of amiodarone within 3 months before enrollment
- Recent or prior pericarditis within 3 months
- History of rheumatic fever
- Prior medical procedures involving the left atrium
- Severe gastrointestinal problems affecting esophagus or stomach or untreated acid reflux
- Bleeding or clotting disorders
- Contraindications to anticoagulation therapy
- Active cancer or cancer treated within past 24 months
- Infection or sepsis on day of procedure
- Recent stroke, transient ischemic attack, or neurological damage
- Severe heart failure or recent hospitalizations for heart failure
- Body mass index over 35 kg/m2
- Kidney dysfunction or dialysis history
- Untreated serious low blood pressure or heart rate problems
- Major surgery, heart attack, unstable angina, or other cardiac events within 3 months
- Organ transplant history or evaluation
- Severe lung disease or pulmonary hypertension
- Any significant uncontrolled medical condition
- Life expectancy less than one year
- Psychological conditions affecting protocol adherence
- Women who are pregnant, nursing, or planning pregnancy during study
- Other factors deemed unsuitable by investigator such as uncontrolled addiction or congenital disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus immediate post-procedure period
Participants undergo the CellFX nano-PFA 360 Endocardial Ablation Catheter System procedure to treat atrial fibrillation.
1 procedure visit and 1 immediate post-procedure electroanatomical mapping visit
Duration - Up to 12 months post-procedure
Participants are monitored for safety and effectiveness of the treatment with assessments up to 12 months after the procedure.
Electroanatomical mapping at 3 months post-procedure and additional follow-up visits over 12 months
Trial Site Locations
Total: 3 locations
1
Hartcentrum Hasselt Research Center /Jessa Hospital
Hasselt, Belgium
Active, Not Recruiting
2
Na Homolce Hospital
Prague, Czechia
Actively Recruiting
3
Policlinico Tor Vergata Hospital
Roma, Italy
Actively Recruiting
Research Team
W
William A. Knape
A
Aleksandra Kurek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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