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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCardioFocus

About this trial

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 criteria

Qualifiers

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

Disqualifiers

overall good health as established by multiple criteria

Trial design

Treatments tested in this trial

  • pulsed field ablation

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators