Clinical Trial

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

Study acronym: VISION AF
Recruiting
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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.
Protocol Amendment History 3 changes
notable Enrollment increased: 75 -> 100 participants 2026-08-04
notable Primary completion pushed: 2026-03-31 -> 2027-03-31 2026-08-04
minor Completion pushed: 2026-05-31 -> 2027-12-31 2026-08-04
Trial Details
NCT Number NCT06828939
Lead Sponsor CardioFocus
Conditions Atrial Fibrillation (Paroxysmal)
Enrollment 100 participants
Start Date 2024-12-12
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-03