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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation (Paroxysmal)

In brief

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.

Key facts

Study ID

NCT06828939

Run by

CardioFocus

People needed

100

Starts

2024-12-12

Expected to finish

2027-12-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• overall good health as established by multiple criteria

Where it is running

• Na Homolce Hospital — Prague, Czech Republic, Czechia (enrolling)

Full record on ClinicalTrials.gov

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