ClinicalTrials.gg
Sign In
RecruitingNCT07271238INSiGHTUpdated Nov 3, 2026

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

An interventional study of VERAFEYE Imaging and Guidance System in Atrial Fibrillation, Atrial Flutter and Atrial Arrhythmia, sponsored by LUMA Vision Ltd.. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by LUMA Vision Ltd. · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Nov 3, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Atrial Arrhythmia
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

LUMA Vision Ltd. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site

Exclusion criteria

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- 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: 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceVERAFEYE 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.

06

What researchers measure

Primary outcomes

  1. ADEs

    • Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure

    Time frame: within 7 days of the index procedure

  2. 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

    Time frame: during procedure

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 9 months is below that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Oct 2026 → Dec 2026 and completion Oct 2026 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2025
First posted
Dec 9, 2025
StartActual
Mar 3, 2026
Primary completionEst.
Dec 15, 2026was Oct 2026
CompletionEst.
Dec 15, 2026was Oct 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Oct 15, 2026→Dec 15, 2026
Nov 3, 2026
Study completion
Oct 15, 2026→Dec 15, 2026
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Primary completion Oct 15, 2026→Dec 15, 2026
    Study completion Oct 15, 2026→Dec 15, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07271238
Lead sponsor
LUMA Vision Ltd.
Responsible party
Sponsor
First posted
Dec 9, 2025
Start date
Mar 3, 2026
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Nov 3, 2026

Study contacts

Ivan Sikiric
Contact
ivan.sikiric20@gmail.com
+385958934912
Ivan Aranza
Contact
aranza.ivan@gmail.com
+385917947452

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrial Fibrillation →

Other studies from this sponsor

LUMA Vision Ltd.

Start the discussion