Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

Exclusion Criteria

• •1. In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial \[LA\] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation.
• •2. Any duration of continuous AF lasting longer than 12 months.
• •3. History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
• •4. AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
• •5. Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test).
• •6. New York Heart Association (NYHA) Class III or IV.
• •7. Left atrial diameter \> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \>100mL if left atrial diameter is not available.
• •8. Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable/insertable cardiac loop recorder/monitor at the time of the ablation procedure.
• •9. Body mass index (BMI) \>40.
• •10. Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
• •11. Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
• •12. Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
• •13. Presence of pulmonary vein abnormalities of stenosis or stenting.
• •14. Primary pulmonary hypertension.
• •15. Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline).
• •16. Pre-existing hemi-diaphragmatic paralysis.
• •17. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant.
• •18. Rheumatic heart disease.
• •19. Unstable angina or ongoing myocardial ischemia.
• •20. Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \>15mm).
• •21. History of blood clotting or bleeding disease (e.g., thrombocytosis).
• •22. History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.
• •23. Active systemic infection.
• •24. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma, or non-metastatic prostate or breast cancer with life expectancy remaining \>1 year).
• •25. Pregnant or lactating (current or anticipated during study follow-up).
• •26. Current enrollment in any other clinical study where testing or results from that study may interfere with the procedure or outcomes measurement for this study.
• •27. Any other condition that, in the judgment of the Investigator, makes the patient:
• •1. Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or
• •2. A poor candidate for the study (e.g., vulnerable patient population, mental illness, addictive disease, terminal illness, and extensive travel away from the research center).