Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures (INSiGHT)

The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).

Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Flutter; Atrial Arrhythmia
• Intervention / Treatment: Device: VERAFEYE Imaging and Guidance System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Sikiric; Phone Number: +385958934912; Email: ivan.sikiric20@gmail.com
• Study Contact Backup: Name: Ivan Aranza; Phone Number: +385917947452; Email: aranza.ivan@gmail.com

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • Klinicki Bolnicki Centar (KBC) Split
    • Principal Investigator: Ante Anic
    • Contact: Ivan Sikiric; Phone Number: +385958934912; Email: ivan.sikiric20@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• IC1: Subject is at least 18 years of age at the time of consent
• IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local guidelines and per physician discretion
• IC3: Subject is able to understand and willing to provide written informed consent
• IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site

Exclusion Criteria:

• EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
• EC2: 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)
• EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
• EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
• EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
• EC6: Life expectancy less than 12 months
• EC7: Current LA thrombus Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.
• EC8: Subjects who are currently enrolled in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Atrial Fibrillation and Atrial Flutter arm; Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation	Device: VERAFEYE Imaging and Guidance System; The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADEs	• Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure	within 7 days of the index procedure
VERAFEYE Performance	• Ability of VERAFEYE Imaging and Guidance System to: Visualize major cardiac structures (e.g. RA, septum, LA, PVs); Create 3D anatomical model with the VERAFEYE Imaging and Guidance System	during procedure

Collaborators and Investigators

• Sponsor: LUMA Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 9, 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; Atrial Flutter
• Other Study ID Numbers: INSiGHT-P005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No