MedTrace Logo

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

NCT06828939 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-10-07

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (Paroxysmal)

Interventions

DEVICE

pulsed field ablation

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

Sponsors & Collaborators

  • CardioFocus

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-03-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828939 on ClinicalTrials.gov