Actively Recruiting
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-01-12
30
Participants Needed
6
Research Sites
178 weeks
Total Duration
On this page
Sponsors
P
Pulse Biosciences, Inc.
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
CONDITIONS
Official Title
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 85 years old
- Able and willing to provide informed consent and complete follow-up visits
- History of documented atrial fibrillation within one year before enrollment
- Scheduled for non-emergent cardiac surgery on cardiopulmonary bypass, including mitral or aortic valve repair/replacement, ascending aortic aneurysm repair, or coronary artery bypass
- Left ventricular ejection fraction of 30% or higher based on recent heart tests
- Life expectancy of at least 5 years
You will not qualify if you...
- Presence of implantable electronic medical devices such as pacemaker, ICD, CRT, or left atrial appendage device
- Having a prosthetic heart valve
- Stand-alone atrial fibrillation without need for concomitant coronary artery bypass or valve surgery
- Previous surgical Maze procedure or prior cardiac surgery
- Diagnosed with Wolff-Parkinson-White syndrome or other supraventricular arrhythmias
- Need for surgeries other than coronary artery bypass, valve surgery, or atrial septal defect repair
- Prior left atrium instrumentation like previous ablation
- Class IV heart failure symptoms
- Stroke or transient ischemic attack within 6 months or with lasting neurological deficits
- Recent heart attack within 6 weeks
- Need for emergent cardiac surgery
- Severe carotid artery narrowing above 80%
- Active systemic infection
- Severe peripheral arterial disease causing claudication with minimal exertion
- Renal failure requiring dialysis or liver failure
- Known drug or alcohol addiction
- Mental impairment or conditions affecting understanding of the study
- Pregnancy or plans to become pregnant within 12 months
- Preoperative need for intra-aortic balloon pump or intravenous inotropes
- Previous thoracic radiation treatment
- Current chemotherapy
- Long-term steroid treatment (excluding intermittent inhaled steroids)
- Known hypertrophic obstructive cardiomyopathy
- Known cold agglutinin disease
- History of abnormal bleeding or clotting disorders
- Contraindications to anticoagulation medications
- Solid organ or blood-related transplant or evaluation for transplant
- Body mass index over 40 kg/m2
- Use of other investigational therapies within 30 days or participation in another research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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