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Which imaging guide leads to better outcomes in heart ablation?

NCT ID NCT07772518

Disease control Sponsor: Mitera Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial compares two ways of guiding a heart procedure called pulsed field ablation, used to treat paroxysmal atrial fibrillation (an irregular heartbeat that comes and goes). About 292 people scheduled for this ablation will be randomly assigned to have the procedure guided by either intracardiac echocardiography (an ultrasound inside the heart) or a 3D electroanatomical mapping system. The goal is to see which method better prevents abnormal heart rhythms from returning within a year and which has fewer complications.

What this could mean

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

Active substance
Pulsed field ablation procedure guided by either intracardiac echocardiography or electroanatomical mapping
What this could lead to
If successful, this could identify the better imaging strategy to guide pulsed field ablation, potentially improving long-term freedom from atrial fibrillation and reducing complications.
What could go wrong
The trial is relatively small and may not detect subtle differences. Results depend on operator skill and may not generalize to all centers. Risks include procedure-related complications like stroke, bleeding, or heart damage.

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 292 people

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

Started

Aug 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * History of paroxysmal AF. * Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system. Exclusion Criteria: * Any contraindication to AF catheter ablation. * History of previous left atrial ablation. * Need for additional ablation beyond pulmonary vein isolation. * Inability to provide written informed consent. * Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety. * eGFR \< 30 mL/min/1.73 m2 * NYHA class III/IV heart failure * Major cardiovascular events within 90 days * Secondary AF owing to reversible causes * Intracardiac thrombus or other conditions making left atrial instrumentation unsafe * Severe valvular disease

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation (PAF)

How to take part

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

  1. The places running it

    8 sites in 8 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

  • Department of Arrhythmology, Institute of Cardiovascular Diseases

    NOT_YET_RECRUITING

    Banská Bystrica, Slovakia

  • Department of Cardiology, IKEM

    NOT_YET_RECRUITING

    Prague, Czechia

  • Grochowski Hospital, Centre of Postgraduate Medical Education

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Heart and Vascular Center, Semmelweis University

    NOT_YET_RECRUITING

    Budapest, Hungary

  • Hygeia Hospital, 8th Cardiology Department

    RECRUITING

    Athens, Greece

  • Marche Polytechnic University / Marche University Hospital

    NOT_YET_RECRUITING

    Ancona, Italy

  • University Hospital Centre Zagreb (KBC Zagreb)

    NOT_YET_RECRUITING

    Zagreb, Croatia

  • University Medical Centre Ljubljana (UKC Ljubljana)

    NOT_YET_RECRUITING

    Ljubljana, Slovenia

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