Actively Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Led by LUMA Vision Ltd. · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years of age at the time of consent
- 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
- Subject is able to understand and willing to provide written informed consent
- Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
You will not qualify if you...
- 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
- Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
- Unrecovered or unresolved adverse events from any previous invasive procedure
- Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- Life expectancy less than 12 months
- Current left atrial thrombus detected within 48 hours prior to or during the index procedure
- Subjects currently enrolled in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Klinicki Bolnicki Centar (KBC) Split
Split, Croatia, 21000
Actively Recruiting
Research Team
I
Ivan Sikiric
CONTACT
I
Ivan Aranza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here