Actively Recruiting
Pulse Biosciences CellFX nsPFA Cardiac Surgery Clamp System for Treating Atrial Fibrillation During Heart Surgery
Led by Pulse Biosciences, Inc. · Updated on 2026-01-12
135
Participants Needed
2
Research Sites
87 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 CellFX nsPFA Cardiac Surgery System for treating atrial fibrillation (AF) in adults undergoing heart surgery. This prospective, multicenter, non-randomized single-arm study focuses on adults aged 18 to 85 with paroxysmal or persistent AF who are scheduled for cardiac surgery involving cardiopulmonary bypass. The goal is to assess the safety and effectiveness of this device during concomitant cardiac surgical procedures. Participants will receive cardiac ablation using the CellFX nsPFA Cardiac Clamp system during their open-heart surgery. The procedure includes isolation of the left and right pulmonary veins and the left atrial posterior wall via roof and floor lesions, forming a box lesion set. Left atrial appendage exclusion or removal is also performed. The left atrial posterior wall isolation can be achieved by either an epicardial lesion or a combined epicardial and endocardial approach when the left atrium is open. During the study, participants will be monitored for freedom from atrial arrhythmias lasting more than 30 seconds and freedom from increased use of certain antiarrhythmic drugs from 3 to 6 months after the procedure. Safety is tracked by recording major adverse events such as death, stroke, heart attack, or bleeding within 30 days after surgery. Follow-up includes assessments of electrical isolation immediately after ablation and patient-reported quality of life at 6 and 12 months. The total participation period includes baseline, procedure, and follow-up visits up to 12 months.
CONDITIONS
Brief Title
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp 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
- Willing and able to provide informed consent and complete follow-up visits
- History of documented paroxysmal or persistent/longstanding persistent atrial fibrillation within one year prior to enrollment
- Scheduled for non-emergent cardiac surgery involving cardiopulmonary bypass including mitral or aortic valve repair/replacement, ascending aortic aneurysm, atrial septal defect or patent foramen ovale repair, or coronary artery bypass
- Left ventricular ejection fraction of 30% or higher
- Life expectancy of at least 5 years
- Lives within reasonable commuting distance and plans to remain stable geographically through 12 months follow-up
You will not qualify if you...
- Presence of implantable electronic medical devices such as pacemaker, ICD, CRT, or left atrial appendage device
- History or presence of left atrial appendage clot
- Prosthetic heart valve
- Stand-alone atrial fibrillation without indication for CABG or valve surgery
- Prior cardiac surgery including prior surgical ablation
- Left atrial diameter 6 cm or greater
- Wolff-Parkinson-White syndrome or other supraventricular arrhythmias
- Persistent atrial fibrillation longer than 10 years
- Need for surgery other than CABG, valve surgery, atrial septal defect/PFO repair, or ascending aorta surgery
- Prior left atrial instrumentation such as previous ablation
- Use of antiarrhythmic drugs for ventricular arrhythmia
- High predicted surgical mortality risk (STS PROM 10 or higher)
- Severe heart failure symptoms (Class III or IV NYHA)
- Stroke within past 6 months
- Recent myocardial infarction within 6 weeks
- Need for emergent cardiac surgery
- Significant carotid artery stenosis over 80%
- Active systemic infection
- Severe peripheral arterial disease with minimal exertion
- Renal failure requiring dialysis or significant liver failure
- Known drug or alcohol addiction
- Mental impairment preventing understanding of study
- Pregnancy or desire to become pregnant within 12 months
- Preoperative need for intra-aortic balloon pump or intravenous inotropes
- Prior thoracic radiation or current chemotherapy
- Long-term steroid treatment (except intermittent inhaled steroids)
- Known hypertrophic obstructive cardiomyopathy
- Known cold agglutinin
- Contraindications to anticoagulation
- Organ transplant or evaluation for transplant
- Body mass index over 45 kg/m2
- Diagnosed connective tissue disorder
- Severe chronic obstructive pulmonary disease
- Use of other investigational drugs 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.
Duration - Day of surgery plus 30 days post-surgery
Participants undergo cardiac surgery with the CellFX nsPFA Cardiac Surgery Clamp System for atrial fibrillation treatment, including ablation and left atrial appendage exclusion or removal.
1 surgical procedure visit and multiple post-operative visits within 30 days
Duration - Up to 12 months post-surgery
Participants are monitored for safety and effectiveness outcomes including heart rhythm assessments and quality of life measures following surgery and ablation.
Visits at 3, 6, and 12 months post-procedure
Trial Site Locations
Total: 2 locations
1
Adventist Heart Institute: Adventist Health St. Helena
St. Helena, California, United States, 94574
Actively Recruiting
2
Cardiac Surgery Clinic | Frankel Cardiovascular Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
S
Shweta Kalpa, MD
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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