RecruitingNot ApplicableNCT06959121

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation

Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery

Sponsor

Pulse Biosciences, Inc.

Enrollment

135 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Ablation Maze Procedure AF

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 cardiac surgical procedures.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

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 Criteria35

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