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

Inclusion Criteria:

• Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment

• Subject is willing and capable of providing Informed Consent to undergo studyprocedures and participate in all examinations and follow-up visits and testsassociated with this clinical study

• Subjects with PAF who have had at least one AF episode documented within one (1)year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip

• Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, orAV nodal blocking agents such as beta blockers and calcium channel blockers) asshown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blockingagents

• Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracicechocardiography (TTE) or computed tomography (CT) within 3 months prior to theprocedure

• Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months priorto the procedure

• Received a standard cardiac work up and is an appropriate candidate for aninvestigational procedure as determined by the study investigators

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-cardiaccause

• 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 TTEexamination

• 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 appendageocclusion)

• History of severe chronic gastrointestinal problems involving the esophagus, stomachand/or untreated acid reflux

• History of abnormal bleeding and/or clotting disorder

• Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin KAntagonists 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 eitherfever, leukocytosis or requiring intravenous antibiotics

• History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhageor permanent neurological deficit

• New York Heart Association (NYHA) class IIIb or IV congestive heart failure and/orany 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 receivedhemodialysis

• History of untreated and serious hypotension, bradycardia or chronotropicincompetence

• 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 organtransplant

• 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 (suchas uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism orsignificant coagulation disorder)

• Life expectancy less than one year

• Clinically significant psychological condition that in the physician's opinion wouldprohibit the subject's ability to meet the protocol requirements.

• Females of childbearing potential who are nursing, pregnant, or planning to becomepregnant during the study period

• Other criteria, which the Investigator determines would make the patient unsuitableto participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease,fragility)