Actively Recruiting
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
Led by Pulse Biosciences, Inc. · Updated on 2026-01-12
135
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
Sponsors
P
Pulse Biosciences, Inc.
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
CONDITIONS
Official 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
- Subject is willing and able to give informed consent and complete follow-up visits
- Subject has documented paroxysmal or persistent/longstanding persistent atrial fibrillation within one year prior to enrollment
- Subject is scheduled for non-emergency cardiac surgery including mitral or aortic valve repair/replacement, ascending aortic aneurysm repair, atrial septal defect or patent foramen ovale repair, or coronary artery bypass graft
- Left ventricular ejection fraction of 30% or higher
- Subject has a life expectancy of at least 5 years
- Subject lives within reasonable distance of the study site and plans to remain stable for 12 months follow-up
You will not qualify if you...
- Subject has an implanted electronic medical device such as pacemaker, ICD, cardiac resynchronization therapy device, or left atrial appendage device
- Presence or history of left atrial appendage clot
- Subject has a prosthetic heart valve
- Stand-alone atrial fibrillation without indication for concomitant CABG or valve surgery
- Prior cardiac surgery including prior surgical ablation
- Left atrial diameter of 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 repair, or ascending aorta surgery
- Prior left atrial instrumentation such as previous ablation
- Use of antiarrhythmic drugs for ventricular arrhythmia
- STS predicted risk of mortality of 10 or higher
- Class III or IV heart failure symptoms
- Stroke within 6 months prior
- Myocardial infarction within 6 weeks prior
- Need for emergent cardiac surgery
- Known carotid artery stenosis over 80%
- Active systemic infection
- Severe peripheral arterial disease causing claudication with minimal exertion
- Renal failure requiring dialysis or severe liver failure
- Known drug or alcohol addiction
- Mental impairment preventing understanding of the study
- Pregnancy or plans to become pregnant within 12 months
- Preoperative need for intra-aortic balloon pump or intravenous inotropes
- Prior thoracic radiation therapy
- Current chemotherapy
- Long-term steroid treatment except intermittent inhaled steroids
- Known hypertrophic obstructive cardiomyopathy
- Known cold agglutinin disease
- Contraindication to anticoagulation
- Organ transplant recipient or evaluation for transplant
- Body mass index above 45 kg/m2
- Diagnosed connective tissue disorder
- Severe chronic obstructive pulmonary disease
- Participation in other investigational drug, therapy, or device studies within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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