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Recruiting NCT06828939

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

No phase Interventional Atrial Fibrillation (Paroxysmal)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulsed field ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (Paroxysmal). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Primary Effectiveness Endpoint - Acute Procedure Success [Time frame: During procedure]
  • Primary Safety Endpoint - Rate of Primary Serious Adverse Events [Time frame: 7 days (unless otherwise specified)]
Secondary outcome measures (2)
  • Secondary Effectiveness Endpoint - Chronic Durability [Time frame: 90 days]
  • Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia [Time frame: 12 months]

Eligibility criteria

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

Exclusion criteria

  • overall good health as established by multiple criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Na Homolce Hospital — Prague

Publications

  • Reddy VY, Petru J, Funasako M, Koruth JS, Neuzil P. Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study. JACC Clin Electrophysiol. 2026 Apr 23:S2405-500X(26)00364-6. doi: 10.1016/j.jacep.2026.04.009. Online ahead of print. PMID 42024567

Identifiers

NCT: NCT06828939 · 25-6073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗