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Heart procedure showdown: which ablation system sends fewer clots to the brain?

NCT ID NCT07610018

Knowledge-focused Sponsor: Ivan Zeljkovic Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare five different pulsed field ablation systems used to treat atrial fibrillation (an irregular heartbeat). The goal is to see which system causes the fewest tiny clots (microemboli) that travel to the brain during the procedure. One hundred adults with atrial fibrillation will be randomly assigned to one of the systems, and a special ultrasound will measure brain clots before and after the procedure.

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 systems (PulseSelect, Varipulse, Farapulse, Sphere-9, Sphere-360)
What this could lead to
If one system causes fewer microemboli, it may become the preferred choice for safer atrial fibrillation ablation.
What could go wrong
This is an early-stage, small study (100 participants) that only measures a surrogate marker (microemboli), not actual stroke risk. Results may not change practice.

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 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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: * Age 18 years or older * Paroxysmal or persistent atrial fibrillation * Indication for catheter ablation with pulmonary vein isolation * Feasibility of transcranial Doppler assessment * Signed informed consent Exclusion Criteria: * Recent stroke or transient ischemic attack * Significant cerebrovascular disease preventing reliable transcranial Doppler assessment * Severe valvular or structural heart disease * Pregnancy or breastfeeding * Inability to receive anticoagulation

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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.

Ablation of arrhythmia's

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

  • UH Dubrava

    Zagreb, 10000, Croatia

  • University Hospital Center Sisters of Charity, Zagreb, Croatia

    Zagreb, 10000, Croatia

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