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

Exclusion Criteria

• •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:
• •1. Major surgery except for the index procedure
• •2. Myocardial infarction
• •3. Unstable angina
• •4. Percutaneous coronary intervention
• •5. Sudden cardiac death event
• •6. 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)