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

Summary

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.

Eligibility

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

Conditions2

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