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AI maps heart's faulty signals to boost AFib treatment

NCT ID NCT06935591

Disease control Sponsor: Vektor Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether adding an AI-powered heart mapping system (vMap) to the standard ablation procedure helps treat atrial fibrillation (AF) better than ablation alone. About 423 adults with persistent or recurrent AF will be randomly assigned to either standard treatment or standard treatment plus vMap guidance. The main goal is to see if more people stay free of AF for 12 months after the procedure.

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 423 people

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

Started

Jun 2025

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.

Ages

22 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: 1. Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study. 2. Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format. 3. The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®): * Atrial fibrillation type * Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s). 4. Subject is ≥ 22 years of age at time of enrollment/consent. 5. Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator. 6. Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, Exclusion Criteria: 1. Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis). 2. Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads. 3. Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation. 4. Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation. 5. Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice. 6. Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

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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 fibrillation (AF)

How to take part

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

  1. The places running it

    13 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

  • Arrhythmia Research Group - St. Bernards

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Baptist Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baptist Health Lexignton

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • BayCare Health System

    RECRUITING

    Clearwater, Florida, 33759, United States

  • German Heart Center

    RECRUITING

    Munich, 80636, Germany

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • OhioHealth

    RECRUITING

    Columbus, Ohio, 43202, United States

  • Penn Presbyterian

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4238, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Piedmont Heart of Athens

    NOT_YET_RECRUITING

    Athens, Georgia, 30606, United States

  • USF Health

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Toledo Medical Center

    NOT_YET_RECRUITING

    Toledo, Ohio, 43614, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

More trials for these conditions

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