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NCT Number: NCT06828939

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

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.

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Key information

Conditions

Atrial Fibrillation (Paroxysmal) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Na Homolce Hospital

Prague, Czech Republic, Czechia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Field Ablation

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint - Acute Procedure Success

    Time frame: During procedure

    Pulmonary vein isolation at the end of the index procedure

  2. Primary Safety Endpoint - Rate of Primary Serious Adverse Events

    Time frame: 7 days (unless otherwise specified)

    The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified:

    • AE fistula (assessed at >=60 days)
    • Cardiac perforation, tamponade, or pericardial effusion
    • Complete heart block
    • Death
    • Major vascular access complications/bleeding requiring surgical intervention or blood transfusion
    • MI
    • Pericarditis
    • PNI resulting in persistent diaphragmatic paralysis (assessed at <=60 days)
    • PV stenosis (assessed at <=60 days)
    • Stroke/CVA
    • Thromboembolism
    • TIA
    • Vagal nerve injury/gastroparesis

Secondary outcomes

  1. Secondary Effectiveness Endpoint - Chronic Durability

    Time frame: 90 days

    Percentage of treated PVs with documented PVI at the remapping procedure

  2. Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia

    Time frame: 12 months

    Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of > 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Hausmann, MPH

CONTACT

[email protected]

508-658-7253

Vikramaditya Mediratta, MS

CONTACT

[email protected]

714-717-2376

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Official study title

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

Acronym: VISION AF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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