Actively Recruiting
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
Led by Pulse Biosciences, Inc. · Updated on 2026-05-06
215
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 self-terminating episodes within six months
- Age between 18 and 85 years old (or older than 18 if local law permits)
- Failure of at least one class I or III anti-arrhythmic drug due to recurrence or side effects
- Ability and willingness to provide informed consent
- Completion of standard cardiac evaluation and deemed appropriate for investigational ablation by study doctors
You will not qualify if you...
- Left atrial diameter equal to or greater than 5.5 cm (anteroposterior)
- Any cardiac surgery, myocardial infarction, coronary intervention, unstable angina, pericarditis, or symptomatic pericardial effusion within 3 months
- Any stroke, transient ischemic attack, or thromboembolic event within 6 months
- Previous procedures involving the left atrium such as ablation, atrial septal defect closure, or left atrial appendage occlusion
- Planned procedures like LAA closure, TAVR, Mitraclip, ASD/PFO closure, Triclip, or cardiac device implantation during the study follow-up
- Not on oral anticoagulation therapy for at least 3 weeks before ablation
- Presence of left atrial thrombus on imaging within 48 hours before procedure
- Presence of permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator
- Prior diagnosis of pulmonary vein stenosis
- History of valvular cardiac surgery or prosthetic valve
- Moderate to severe mitral valve stenosis or significant mitral regurgitation
- NYHA Class III or IV congestive heart failure or LVEF ≤35%
- Pulmonary hypertension with systolic pressure >50 mm Hg, severe COPD, or restrictive lung disease
- Rheumatic heart disease
- Contraindications to anticoagulation
- Active systemic infection
- Hypertrophic or advanced infiltrative cardiomyopathy
- Atrial myxoma
- Known reversible causes of atrial fibrillation like uncontrolled hyperthyroidism or severe untreated sleep apnea
- History of abnormal bleeding or clotting disorders
- Severe renal insufficiency or history of dialysis or transplant
- Severe chronic gastrointestinal problems or untreated acid reflux
- Solid organ or hematologic transplant or evaluation for transplant
- Pregnancy, breastfeeding, or women not using reliable birth control
- Other conditions making participation unsuitable per investigator
- Body Mass Index over 40
- Significant uncontrolled or unstable medical conditions
- Life expectancy less than one year
- Participation in other clinical studies not approved by sponsor
- Unwillingness or inability to comply with study procedures and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Roentgenova, Czechia, 37/2
Actively Recruiting
Research Team
M
Micki Weisman
CONTACT
W
William A. Knape
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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