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

Exclusion Criteria

• •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