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New heart mapping tech could improve AFib treatment

NCT ID NCT06529978

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study tests a new mapping system (CoreMap) to help doctors treat persistent atrial fibrillation (AFib), a type of irregular heartbeat. About 245 adults with persistent AFib will have a standard procedure called ablation, but with the CoreMap system guiding the treatment. The goal is to see if the system is safe and helps prevent AFib from coming back for at least 12 months.

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 245 people

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

Started

Jul 2024

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 to 80 years

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. Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2) 2. Subject has PerAF with no history of prior AF ablation therapy (Phase 3) 3. Subject is 18 to 80 years of age 4. Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2) 5. Subject is able to provide written informed consent 6. Subject is able and willing to complete all study procedures Exclusion Criteria: 1. Any of the following within three months of enrollment: 1. Myocardial infarction (MI) 2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation 3. Confirmed thrombus on imaging 2. Any of the following within six months of enrollment: 1. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy 2. Thromboembolic event (stroke) 3. Any of the following cardiac conditions: 1. New York Heart Association (NYHA) IV 2. Left ventricular ejection fraction (LVEF) \< 30% 3. Left atrial diameter \>55mm (anterioposterior) (Phase 3) 4. Carotid stenting or endarterectomy 5. Atrial or ventricular septal closure or left atrial appendage closure 6. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted. 7. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation 8. Unstable angina 9. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve 10. Moderate to severe mitral valve stenosis or other severe valvular disease 11. Any blood clotting or bleeding abnormalities 4. Contraindication to systemic anticoagulation 5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause 6. Body mass index (BMI) \> 40 kg/m2 7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition 8. Renal failure requiring dialysis or transplant 9. Acute illness, active systemic infection, or sepsis 10. Active drug or alcohol dependency 11. Hypertrophic cardiomyopathy or cardiac amyloidosis 12. Cor pulmonale 13. Any contra-indication that may extend procedure time, at the discretion of the operator 14. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence 15. Subject considered part of vulnerable population 16. Life expectancy less than one year 17. Employee of the study site or Sponsor 18. Subjects who are currently enrolled in another study that would directly interfere with this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 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

  • NCH Downtown Baker Hospital

    ENROLLING_BY_INVITATION

    Naples, Florida, 34102, United States

  • Na Homolce Hospital

    RECRUITING

    Praha Klanovice, Czechia

  • University of Vermont Medical Center

    ENROLLING_BY_INVITATION

    Burlington, Vermont, 05401, United States

  • Virginia Commonwealth University (VCU)

    ENROLLING_BY_INVITATION

    Richmond, Virginia, 23284, United States

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