Catheter Ablation Using a Novel Navigation and Imaging System (ENVIsIoN)

The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Study Overview

• Status: Not yet recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: VERAFEYE System

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Elke Sommerijns; Phone Number: +32479767156; Email: elke.sommerijns@lumavision.com
• Study Contact Backup: Name: Alisa Komleva; Phone Number: +353894352047; Email: alisa.komleva@lumavision.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

• Subjects who have undergone a previous cardiac ablation for the treatment of PAF
• Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
• Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
• Unrecovered/unresolved Adverse Events from any previous invasive procedure
• Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)

Description

Inclusion Criteria:

• Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
• Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
• Subject is able to understand and willing to provide written informed consent
• Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center

Exclusion Criteria:

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success rates during the index procedure	A procedure will be defined as successful if all the following conditions occur during the case: ability to create a 3D anatomical model with the VERAFEYE System and; completion of the necessary ablation applications for PAF using the 3D anatomical model created with the VERAFEYE System	During the procedure

Collaborators and Investigators

• Sponsor: LUMA Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: ENVISION-P003

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