Actively Recruiting
Safety and Effectiveness of the CellFX nsPFA Catheter Endocardial Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-05-06
215
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF). This prospective, multicenter, non-randomized clinical investigation focuses on patients with paroxysmal AF who require catheter ablation and have not responded well to medications. The study aims to assess outcomes primarily six months after the procedure using this novel device. Eligible participants undergo ablation using the CellFX nsPFA Cardiac Catheter System, which includes the nsPFA 360 Endocardial Ablation Catheter and related components. This system uses nonthermal nanosecond pulses of electrical energy to target cardiac tissue in a cell-specific manner, aiming to disrupt cells that contribute to arrhythmia. The treatment is delivered through an endocardial catheter during a cardiac electrophysiology procedure. The primary endpoints focus on safety and treatment success at 6 months post-ablation. Participants will be involved in the ablation procedure and followed for assessments of safety and efficacy at 7 days, 30 days, and 6 months after treatment. Researchers will monitor freedom from treatment failure and safety endpoints, as well as acute procedural success immediately post-ablation. Participants will undergo standard cardiac evaluation before the procedure and careful follow-up afterward to track outcomes and any adverse effects throughout the study period.
CONDITIONS
Brief Title
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation with at least two episodes of self-terminating AF in the past 6 months
- Age 18 through 85 years (or older than 18 if local law applies)
- Failure of at least one class I or III antiarrhythmic drug for AF due to recurrence or side effects
- Willing and capable of providing informed consent
- Completed standard cardiac evaluation and deemed appropriate for investigational procedure by investigators
You will not qualify if you...
- Left atrial diameter greater than or equal to 5.5 cm
- Cardiac surgery, myocardial infarction, PCI/PTCA, coronary stenting, unstable angina, pericarditis, or symptomatic pericardial effusion within 3 months
- Cerebral ischemic event, thromboembolic event within 6 months
- Prior left atrial instrumentation or planned procedures such as LAA closure, TAVR, Mitraclip, ASD/PFO closure, Triclip, ILR, pacemaker, or defibrillator implantation during follow-up
- Not on oral anticoagulation for at least 3 weeks before ablation
- Left atrial thrombus within 48 hours before procedure
- Presence of permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator
- Prior pulmonary vein stenosis
- Valvular cardiac surgery or prosthetic valve
- Moderate to severe mitral valve stenosis or regurgitation
- NYHA Class III or IV heart failure or LVEF ≤ 35%
- Pulmonary hypertension with systolic pressure > 50 mm Hg, severe COPD or restrictive lung disease
- Rheumatic heart disease
- Contraindication to anticoagulation
- Active systemic infection
- Hypertrophic or infiltrative cardiomyopathy
- Atrial myxoma
- Reversible causes of AF such as uncontrolled hyperthyroidism, severe untreated sleep apnea, acute alcohol toxicity
- History of bleeding or clotting disorder
- Renal insufficiency with eGFR < 30 or history of dialysis or transplant
- Severe chronic gastrointestinal problems
- Organ transplant or evaluation for transplant
- Pregnant or breastfeeding women or women not using reliable birth control
- Other conditions making participation unsuitable as determined by investigator
- BMI greater than 40
- Significant uncontrolled or unstable medical conditions
- Life expectancy less than one year
- Participation in another clinical study not approved by sponsor
- Unwilling or unable to comply with study procedures and follow-up
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 - 1 day (procedure day) plus immediate post-procedure monitoring
Participants undergo a catheter ablation procedure using the CellFX nsPFA Cardiac Catheter System to treat paroxysmal atrial fibrillation.
1 procedure visit (in-person) and approximately 1 immediate post-procedure visit
Duration - 6 months
Participants are monitored for safety and treatment effectiveness up to 6 months after the ablation procedure.
Visits at 7 days, 30 days, and multiple assessments up to 6 months post-procedure
Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Roentgenova, Czechia, 37/2
Actively Recruiting
Research Team
M
Micki Weisman
W
William A. Knape
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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