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RECRUITING
NCT06828939
NA

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

Sponsor: CardioFocus

View on ClinicalTrials.gov

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

Interventions

DEVICE

pulsed field ablation

Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.

Locations (1)

Na Homolce Hospital

Prague, Czech Republic, Czechia