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

Prior treatment

• History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
• Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
• Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
• History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.

Other illness

• AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
• New York Heart Association (NYHA) Class III or IV.
• 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.
• Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
• Primary pulmonary hypertension.
• Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline).
• Rheumatic heart disease.
• Unstable angina or ongoing myocardial ischemia.
• History of blood clotting or bleeding disease (e.g., thrombocytosis).
• Active systemic infection.
• 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).
• Any other condition that, in the judgment of the Investigator, makes the patient:
  • Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or
  • 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).

Lab values

• 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).
• Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant.

Other

• 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.
• Any duration of continuous AF lasting longer than 12 months.
• 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.
• Body mass index (BMI) \>40.
• Presence of pulmonary vein abnormalities of stenosis or stenting.
• Pre-existing hemi-diaphragmatic paralysis.
• Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \>15mm).
• Pregnant or lactating (current or anticipated during study follow-up).
• 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.

• Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
• Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
  • Symptomatic paroxysmal AF that is less than 7 days in continuous duration, documented by the following: i. Physician documentation of symptomatic recurrent PAF (2 or more episodes) within 6 months prior to enrollment AND ii. At least 1 documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
  • Symptomatic persistent AF that is sustained beyond 7 days and less than 1 year (≥ 7 and ≤ 365 days), documented by the following: i. Physician documentation of at least 1 symptomatic persistent AF episode within 6 months prior to enrollment.
  • Either a 24-hour continuous ECG recording documenting continuous AF OR 2 ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart, within 6 months prior to enrollment.
• Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
• Willing and able to give informed consent.
• Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
• Life expectancy \>1 year.