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Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Sponsor: CardioFocus
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.
Official title: Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-12-12
Completion Date
2026-05-31
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
pulsed field ablation
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Locations (1)
Na Homolce Hospital
Prague, Czech Republic, Czechia