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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (Paroxysmal)
• Intervention / Treatment: Device: pulsed field ablation

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vikramaditya Mediratta, MS; Phone Number: 714-717-2376; Email: vmediratta@cardiofocus.com
• Study Contact Backup: Name: Lisa Hausmann, MPH; Phone Number: 508-658-7253; Email: lhausmann@cardiofocus.com

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia
      • Recruiting
      • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System	Device: pulsed field ablation; Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint - Acute Procedure Success	Pulmonary vein isolation at the end of the index procedure	During procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events	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	7 days (unless otherwise specified)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness Endpoint - Chronic Durability	Percentage of treated PVs with documented PVI at the remapping procedure	90 days
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia	Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of > 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor	12 months

Collaborators and Investigators

• Sponsor: CardioFocus

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ablation; pulsed field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 25-6073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes