Status:
RECRUITING
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
Lead Sponsor:
Pulse Biosciences, Inc.
Collaborating Sponsors:
Avania
Conditions:
Atrial Fibrillation
Maze Procedure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 car...
Detailed Description
The study design is a prospective, multicenter, non-randomized single arm study. Eligible adult subjects with paroxysmal or persistent/longstanding persistent AF who are eligible to participate will u...
Eligibility Criteria
Inclusion
- Subject must be between 18 and 85 years of age
- Subject is willing and capable of providing Informed Consent to undergo study procedures which include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
- Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and sustains for \> 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovale (PFO) or Coronary artery bypass procedures
- Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
- Subject has a life expectancy of at least 5 years
- Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up
Exclusion
- Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) or left atrial appendage (LAA) device
- Subject has history or known to have LAA clot
- Subject has a prosthetic heart valve
- Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Prior cardiac surgery including prior cardiac surgical ablation
- Left Atrial diameter ≥ 6cm
- Wolff-Parkinson-White syndrome or other Supra-Ventricular Arrhythmia, Atrioventricular (AV) nodal reentry
- Documented history of persistent or long standing persistent atrial fibrillation longer than 10 years
- Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair/PFO and ascending aorta
- Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
- Subjects that are on an AAD for ventricular arrhythmia.
- STS Predicted Risk of Mortality (STS PROM) of 10 or higher
- Class III or IV New York Heart Association (NYHA) heart failure symptoms
- Prior history of stroke within 6 months
- Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (per sit-to-stand (STS) test definition)
- Known carotid artery stenosis greater than 80%
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Renal failure requiring dialysis or hepatic failure (significant liver dysfunction with markedly significant elevation of liver enzymes, such as cirrhosis with decompensation, portal hypertension, or a history of hepatic failure)
- A known drug and/or alcohol addiction
- Mental impairment or other conditions that may not allow the subject to understand the nature, significance, and scope of the study
- Pregnancy or desire to get pregnant within 12 months of the study treatment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Subjects who have been treated with thoracic radiation
- Subjects in current chemotherapy
- Subjects on long-term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
- Subjects with known hypertrophic obstructive cardiomyopathy
- Subjects with known cold agglutinin
- Subject has a contraindication to anticoagulation (e.g., a bleeding or clotting disorder such as Idiopathic Thrombocytopenic Purpura (ITP))
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Body mass index \> 45 kg/m2
- Any diagnosed connective tissue disorder
- Severe Chronic Obstructive Pulmonary Disease (COPD) per sit-to-stand (STS) test definition
- Use of any other investigational drug, therapy, or device within 30 days before enrollment or concurrent participation in another research study
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06959121
Start Date
October 23 2025
End Date
December 1 2028
Last Update
December 17 2025
Active Locations (2)
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1
Adventist Heart Institute: Adventist Health St. Helena
St. Helena, California, United States, 94574
2
Cardiac Surgery Clinic | Frankel Cardiovascular Center
Ann Arbor, Michigan, United States, 48109