AI heart maps may forecast who needs more than a standard ablation for AFib

NCT ID NCT07807423

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests whether artificial intelligence software can predict if atrial fibrillation will return within a year after a standard ablation procedure. Researchers will use the Volta AF-Xplorer II software to map abnormal electrical areas in the hearts of 125 people with persistent atrial fibrillation before and after pulmonary vein isolation. The goal is to see if the location and extent of these abnormal areas, called spatiotemporal dispersion, relate to whether the arrhythmia comes back.

What this could mean

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

Active substance
Volta AF-Xplorer II artificial intelligence software used during catheter ablation to map heart tissue
What this could lead to
If the software's maps predict who will have atrial fibrillation return after ablation, doctors could tailor procedures to reduce repeat episodes.
What could go wrong
This is an observational study, not a treatment test. The software's predictions may not prove reliable, and results may not apply beyond the specific ablation technique used.

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 125 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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: 1. Patient aged 18 years or older. 2. De novo patient candidate for catheter ablation of persistent atrial fibrillation (AF episode \>7 days). 3. Continuous anticoagulation for more than 4 weeks before ablation. 4. Patient giving his signed consent form to participate in the clinical study. 5. Patient affiliated to the French social security. Exclusion Criteria: 1. Contraindication to AF/AT catheter ablation. 2. Major bleeding disorder. 3. Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure. 4. Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure. 5. History of blood clotting or bleeding abnormalities 6. Acute illness or active systemic infection or sepsis 7. Any cardiac surgery within the past 2 months (60 days) (includes PCI) 8. Myocardial infarction within the past 2 months (60 days) 9. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 10. Diagnosed atrial myxoma 11. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter 12. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 13. Unstable angina within the past month 14. Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea) 15. Patient who is or could potentially be pregnant. 16. Person deprived of liberty or under guardianship. 17. Patient's refusal to participate in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

    5 sites. 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

  • CHU Dijon

    Dijon, 21079, France

  • Clinique Rhéna

    Strasbourg, 67000, France

  • Clinique Rhône Durance

    Avignon, 84000, France

  • Hôpital Cardiologique Louis Pradel - HCL

    Bron, 69677, France

  • Hôpital Saint-Joseph Marseille

    Marseille, 13008, France

More trials for these conditions

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