Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

Key Inclusion Criteria:

• Subjects planned for an AF catheter ablation procedure, with a documented history of AF.

• Diagnosis must be confirmed within 12 months before enrollment.
• (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
• Subjects between 18 and 75 years of age, inclusive

Key Exclusion Criteria:

• Patients who have contraindications to open heart surgery
• Patients from an Intensive Care Unit
• Patients with active systemic infection (sepsis)
• Patients who have had previous ablation in the left or right atrium
• Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
• Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
• Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
• Patients with New York Heart Association Class III or IV heart failure
• History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
• Bleeding disorder history
• Patients with a known sensitivity to anesthesia or neuromuscular block agent
• Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
• Myocardial infarction within the last three months
• Atrioventricular (AV) block II° or III°
• Left ventricular ejection fraction (LVEF) of less than 35%
• Unstable angina