Actively Recruiting
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-05-05
60
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 18 to 75 years at enrollment
- Willing and able to provide informed consent for study procedures and follow-up
- Diagnosed with paroxysmal atrial fibrillation with at least one episode documented within 1 year before enrollment
- Failed at least one antiarrhythmic drug or AV nodal blocking agent due to recurrent symptoms or intolerance
- Antero-posterior left atrial diameter of 5.5 cm or less by echocardiography or CT within 3 months prior to procedure
- Left ventricular ejection fraction of 40% or higher by echocardiography within 12 months prior to procedure
- Completed standard cardiac workup and deemed appropriate candidate for the investigational procedure by study investigators
You will not qualify if you...
- Presence of implantable electronic medical device (pacemaker, ICD, CRT) or left atrial appendage device
- Prosthetic heart valve
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible/non-cardiac causes
- Atrial fibrillation episodes lasting more than 7 days
- Previous atrial fibrillation ablation
- Use of amiodarone within 3 months prior to enrollment
- History of pericarditis or recent pericarditis within 3 months
- History of rheumatic fever
- Prior medical procedures involving left atrium instrumentation
- Severe chronic gastrointestinal problems involving esophagus, stomach, or untreated acid reflux
- Abnormal bleeding or clotting disorders
- Contraindications to anticoagulation medication
- Active cancer or treated cancer within past 24 months
- Significant infection or sepsis on day of procedure
- Stroke or TIA within past 6 months or prior intracranial hemorrhage
- Advanced heart failure (NYHA class IIIb or IV) or recent heart failure hospitalization
- Body mass index over 35 kg/m2
- Low kidney function or history of hemodialysis
- Untreated serious hypotension, bradycardia, or chronotropic incompetence
- Major surgery, heart attack, unstable angina, or related cardiac events within 3 months
- Solid organ or hematologic transplant or evaluation for transplant
- Pulmonary hypertension with systolic pressure over 50 mm Hg, severe COPD, or restrictive lung disease
- Other uncontrolled or unstable medical conditions
- Life expectancy less than one year
- Psychological conditions preventing study compliance
- Females who are nursing, pregnant, or planning pregnancy during study
- Other conditions deemed unsuitable by investigators such as uncontrolled addiction or fragility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Aleksandra Kurek
CONTACT
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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