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

Last updated: February 13, 2025
Sponsor: CardioFocus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Cardiac Disease

Treatment

pulsed field ablation

Clinical Study ID

NCT06828939
25-6073
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 orstudy site practice

  • Patient is willing and able to give informed consent/participate in baseline andfollow-up assessments for the duration of the study

Exclusion

Exclusion Criteria:

  • overall good health as established by multiple criteria

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: pulsed field ablation
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
May 31, 2026

Study Description

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 AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Connect with a study center

  • Na Homolce Hospital

    Prague,
    Czech Republic

    Active - Recruiting

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