Actively Recruiting
Initial Safety and Performance of the CellFX nsPFA Cardiac Surgery System for Treating Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-01-12
30
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Pulse Biosciences, Inc.
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the initial safety and effectiveness of the CellFX nsPFA Cardiac Clamp in treating atrial fibrillation during cardiac surgery. This feasibility study involves adult patients who need a concurrent cardiac surgical procedure and aims to perform a box lesion around the four pulmonary veins either alone or as part of a larger surgical ablation set. Participants will undergo left pulmonary vein, roof, and floor ablations to create a left atrial posterior box using the CellFX nsPFA Cardiac Surgery System. This is a single-arm, non-randomized study where all subjects receive this treatment during their scheduled cardiac surgery, such as mitral or aortic valve repair, ascending aortic aneurysm repair, or coronary artery bypass. After surgery, participants will return between 60 and 120 days for a cardiac electrophysiology study with electroanatomical mapping to check the electrical isolation of the pulmonary veins and left atrial posterior wall. Researchers will monitor adverse events within 30 days, assess acute electrical isolation within 24 hours, and track long-term technical success up to 12 months. The study involves follow-up visits and various assessments to evaluate safety and performance over time.
CONDITIONS
Brief Title
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be between 18 and 85 years of age
- Subject is willing and able to provide informed consent and complete follow-up visits
- History of documented atrial fibrillation within one year prior to enrollment
- Scheduled for non-emergent cardiac surgery on cardiopulmonary bypass, including mitral valve repair/replacement, aortic valve repair/replacement, ascending aortic aneurysm repair, or coronary artery bypass
- Left ventricular ejection fraction of 30% or greater
- Life expectancy of at least 5 years
You will not qualify if you...
- Presence of implantable electronic medical device such as pacemaker, ICD, CRT, or left atrial appendage device
- Presence of prosthetic heart valve
- Stand-alone atrial fibrillation without indication for coronary artery bypass or valve surgery
- Previous surgical Maze procedure
- Prior cardiac surgery (redo)
- Wolff-Parkinson-White syndrome or other supraventricular arrhythmia including AV nodal reentry
- Need for surgery other than CABG, valve surgery, or atrial septal defect repair
- Prior medical procedures involving the left atrium, such as previous ablation
- Class IV New York Heart Association heart failure symptoms
- History of cerebrovascular accident or TIA within 6 months or with residual neurological deficit
- Recent ST-segment elevation myocardial infarction within 6 weeks
- Need for emergent cardiac surgery
- Carotid artery stenosis greater than 80%
- Current active systemic infection
- Severe peripheral arterial occlusive disease with minimal exertion claudication
- Renal failure requiring dialysis or hepatic failure
- Known drug or alcohol addiction
- Mental impairment affecting understanding of the study
- Pregnancy or desire to become pregnant within 12 months
- Preoperative need for intra-aortic balloon pump or intravenous inotropes
- Prior thoracic radiation treatment
- Current chemotherapy
- Long-term steroid treatment (excluding occasional inhaled steroids)
- Known hypertrophic obstructive cardiomyopathy
- Known cold agglutinin
- History of bleeding or clotting disorders
- Contraindication to anticoagulation therapy
- Solid organ or hematologic transplant or evaluation for transplant
- Body mass index over 40 kg/m2
- Use of other investigational drugs, therapies, or devices within 30 days or concurrent research participation
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 - Day of surgery plus up to 30 days post-procedure
Participants undergo cardiac surgery with ablation using the CellFX® nsPFA™ Cardiac Surgery System to treat atrial fibrillation.
1 surgical procedure and follow-up visits within 30 days
Duration - 60 to 120 days post-surgical procedure
Participants return to the hospital for a cardiac electrophysiology study to assess electrical isolation of treated areas.
1 visit (in-person)
Duration - Up to 12 months post-procedure
Participants are monitored for safety and long-term technical success up to 12 months after the procedure.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 6 locations
1
Medical University of Vienna
Vienna, Austria
Actively Recruiting
2
Academic Medical Center
Amsterdam, Netherlands
Active, Not Recruiting
3
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
4
Maastricht University Medical Center+ (MUMC+)
Maastricht, Netherlands
Active, Not Recruiting
5
St. Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
6
State Medical Institute of the Ministry of Interior Affairs and Administration
Warsaw, Poland
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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