Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation

Inclusion criteria

• At least 18 years old (or older if required by local law)
• Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
• Willing and capable of providing written informed consent
• Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Exclusion criteria

• Any of the following atrial conditions:

• Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
• Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
• Any prior atrial surgery
• Current atrial myxoma
• Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
• Current left atrial thrombus
• Any of the following cardiovascular conditions:

• History of sustained ventricular tachycardia or ventricular fibrillation
• Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)
• Presence of any of the following cardiac devices or implants:

• Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
• Current implantable loop recorder other than LUX-Dx
• Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
• Left atrial appendage closure or occlusion device
• Clinically significant valvular disease, including:

• Any cardiac valve prosthesis, ring, repair, or clip
• Moderate to severe mitral stenosis
• Moderate to severe aortic stenosis
• Severe mitral regurgitation
• Severe tricuspid regurgitation
• Hypertrophic or amyloid cardiomyopathy
• Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
• Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
• Severe right ventricular dysfunction per investigator assessment
• Any of the following congenital conditions:

• Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies
• Known congenital methemoglobinemia
• Known G6PD deficiency
• Any of the following medical history conditions:

• Solid organ or hematologic transplant, or under evaluation for transplant
• History or current evidence of hemi-diaphragmatic paralysis or paresis
• Prinzmetal angina or severe non-revascularizable coronary disease
• Known coagulopathy or bleeding disorder
• Renal insufficiency, history of dialysis, or renal transplant
• Known allergic reaction to nitroglycerin (excluding hypotension)
• Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure
• Active spinal cord stimulator
• Any of the following baseline conditions:

• NYHA Class III or IV heart failure
• Left ventricular ejection fraction (LVEF) less than 40% within 12 months
• CHA2DS2-VASc score greater than or equal to 5
• Body mass index (BMI) greater than 45.0
• Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally
• Pregnant or lactating at time of procedure
• Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease
• Active malignancy (excluding squamous cell carcinoma)
• Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)
• Known Active systemic infection
• Life expectancy of less than 1 year
• Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)
• Any of the following events within 90 days prior to consent:

• Myocardial infarction, unstable angina, or coronary intervention
• Pericarditis or symptomatic pericardial effusion
• Gastrointestinal bleeding
• Cardiac surgery
• Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding
• Any active non-neurologic thrombus and/or thromboembolic event
• Carotid stenting or endarterectomy
• Heart failure hospitalization
• Uncontrolled diabetes mellitus or HbA1c greater than 8.0%
• Other conditions:

• Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices
• Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation