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New 3D Heart-Mapping device tested in 50-Patient registry

NCT ID NCT06293430

Knowledge-focused Sponsor: LUMA Vision Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study will collect real-world information on the VERAFEYE system, a device that creates 3D images of the heart during procedures to treat atrial fibrillation (an irregular heartbeat) and to close the left atrial appendage (a small pouch in the heart). About 50 adults will take part. The main goal is to see if doctors can successfully use the device to guide the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VERAFEYE System (imaging and navigation device)
What this could lead to
If successful, this registry could show that the VERAFEYE system helps doctors perform heart procedures more accurately and safely.
What could go wrong
This is an early-stage registry with only 50 participants and no comparison group, so results may not prove the device is better than existing methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects will be recruited from the investigator's general patient population. Subjects considered for participation in this study will be entitled to undergo a standard of care PAF ablation and/or LAAC procedure with the VERAFEYE System.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent * Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, 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 at an approved clinical investigational center Key Exclusion Criteria: * Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure * 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)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial arrhythmia Atrial fibrillation Left atrial appendage closure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.