CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation

Exclusion Criteria33

• Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
• Subject has a prosthetic heart valve
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• AF episodes lasting \> 7 days
• Previous ablation for AF
• Subjects on amiodarone at any time during the past 3 months prior to enrollment
• Prior history of pericarditis or pericarditis within 3 months based on the TTE examination
• Prior history of rheumatic fever
• Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion)
• History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
• History of abnormal bleeding and/or clotting disorder
• Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as Warfarin)
• Active malignancy or history of treated cancer within 24 months of enrollment
• Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit
• New York Heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment
• Body mass index \> 35 kg/m2
• Estimate glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 or has ever received hemodialysis
• History of untreated and serious hypotension, bradycardia or chronotropic incompetence
• Any of the following within 3 months of enrollment:
• Major surgery except for the index procedure
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention
• Sudden cardiac death event
• Left atrial thrombus that has not resolved as shown by TEE or CT
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• History of pulmonary hypertension with pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
• Subjects with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)
• Life expectancy less than one year
• Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
• Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period
• Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)