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Smart software aims to make heart ablation more precise

NCT ID NCT07275151

Knowledge-focused Sponsor: CathVision ApS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 4 times

Summary

This study tests a new software module that analyzes heart signals during a procedure called pulsed field ablation, used to treat atrial fibrillation. The goal is to see if the software can accurately tell doctors when the targeted heart veins are fully isolated. One hundred adults having their first ablation will be enrolled, and the software's results will be compared to the doctor's standard assessment.

What this could mean

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

What this could lead to
If successful, this could lead to a more reliable way to confirm that heart tissue has been effectively treated during ablation, potentially improving outcomes for atrial fibrillation patients.
What could go wrong
This is an early, observational study focused on testing software, not a new treatment. It may not lead to any change in clinical practice or patient outcomes.

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 40 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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.

Who is studied

Patients diagnosed with paroxysmal atrial fibrillation and referred for a denovo pulmonary vein isolation ablation procedure using pulsed field ablation

Ages

21 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: Eligible subjects will meet all of the following inclusion criteria: 1. Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation. 2. Male or non-pregnant female aged ≥21 years. 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure. 4. Subjects in sinus rhythm at the time of the PFA application. Exclusion Criteria: Eligible subjects will not meet any of the following exclusion criteria: 1. Pregnant or nursing subjects. 2. Current participation in another investigational drug or device study that interferes with this study. 3. Subjects who, in the opinion of the investigator, are not candidates for this study. 4. Patients who have had a prior ablation procedure. 5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 6. Life expectancy is less than 12 months, in the opinion of the investigator. 7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population. 8. Subjects unlikely to be in sinus rhythm at the time of the procedure or unlikely to remain in sinus rhythm after cardioversion

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

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. 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

  • The Valley Hospital

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • Trinity Health Ann Arbor Hospital

    NOT_YET_RECRUITING

    Ypsilanti, Michigan, 48197, United States

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