Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation

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.

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 AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Inclusion Criteria:

• 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
• Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion Criteria:

• overall good health as established by multiple criteria