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New 3D heart map aims to improve ablation for common heart rhythm problems

NCT ID NCT07210151

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new 3D imaging system that helps doctors see inside the heart during a procedure to treat atrial flutter and atrial fibrillation. About 50 adults who are already scheduled for a catheter ablation will have their procedure guided by this system. The goal is to see how well the system works and gather information to improve it in the future.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Started

Jan 2026

Expected to finish

Dec 2026

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.

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.

Inclusion Criteria: * IC1: Subject is at least 18 years of age at the time of consent * IC2: Subject is scheduled to undergo a 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: Unrecovered/unresolved Adverse Events from any previous invasive procedure * EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure. * EC5: Life expectancy less than 12 months * EC6: 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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial arrhythmia Atrial fibrillation Atrial flutter

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Klinicki Bolnicki Centar (KBC)

    NOT_YET_RECRUITING

    Split, 21000, Croatia

  • Na Homolce Hospital

    RECRUITING

    Prague, 150 30, Czechia

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