This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Recurrent symptomatic PAF with at least one documented episode
Failure or intolerance of at least one AAD
Age 18-75 years
Patient is indicated for an ablation procedure according to society guidelines or study site practice
overall good health as established by multiple criteria
Single group
pulsed field ablation
DevicePulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Primary Effectiveness Endpoint - Acute Procedure Success
Pulmonary vein isolation at the end of the index procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at \>=60 days) * Cardiac perforation, tamponade, or pericardial effusion * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * MI * Pericarditis * PNI resulting in persistent diaphragmatic paralysis (assessed at \<=60 days) * PV stenosis (assessed at \<=60 days) * Stroke/CVA * Thromboembolism * TIA * Vagal nerve injury/gastroparesis
Secondary Effectiveness Endpoint - Chronic Durability
Percentage of treated PVs with documented PVI at the remapping procedure
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia
Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of \> 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor
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