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New balloon ablation could change early AFib treatment

NCT ID NCT07621003

Disease control Sponsor: Asklepios proresearch 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 5 times

Summary

This study tests a procedure called pulsed field ablation (PFA) for people with early-stage atrial fibrillation (AFib) diagnosed within the last 3 years. The procedure uses a balloon to deliver energy that isolates the pulmonary veins, aiming to stop abnormal heart rhythms. Researchers will compare PFA to usual care (medication) in 264 adults over 12 months to see if it reduces AFib episodes and hospitalizations.

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 (a procedure using a balloon to deliver energy to isolate pulmonary veins)
What this could lead to
If successful, this could offer a more effective first-line treatment for early atrial fibrillation, potentially reducing the need for long-term medication.
What could go wrong
This is an early-stage study with 264 participants, so results may not apply to all patients. The procedure carries risks like bleeding, heart damage, or arrhythmia recurrence.

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 264 people

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

Started

Aug 2026

Expected to finish

Mar 2031

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: * Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation * First diagnosis of AF within the last 36 months * At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device * No prior catheter ablation for AF Exclusion Criteria: * Persistent AF \>3 years or longstanding persistent AF * Previous AF-Ablation * Ongoing continuous AAD therapy with Amiodarone at baseline * History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy * Left Atrial Volume Index (LAVI) \> 50mL/m2 * Severe mitral regurgitation * Contraindications to anticoagulation therapy * Severe pulmonary or renal disease * Pregnancy, active cancer disease * Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)

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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

    10 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

  • Arian Sultan

    RECRUITING

    Hamburg, 20099, Germany

  • CCB Frankfurt

    NOT_YET_RECRUITING

    Frankfurt, Germany

  • HZD Bad Oeynhausen

    NOT_YET_RECRUITING

    Bad Oeynhausen, Germany

  • Klinikum Nürnberg

    NOT_YET_RECRUITING

    Nuremberg, Germany

  • Leipzig Herzzentrum HZL

    NOT_YET_RECRUITING

    Leipzig, Germany

  • Lukas Krankenhaus Neuss

    NOT_YET_RECRUITING

    Neuss, Germany

  • Marien Hospital Herne

    NOT_YET_RECRUITING

    Herne, Germany

  • Uniklinik Düsseldorf

    NOT_YET_RECRUITING

    Düsseldorf, Germany

  • Uniklinik Gießen

    NOT_YET_RECRUITING

    Giessen, Germany

  • Uniklinik Köln

    NOT_YET_RECRUITING

    Cologne, Germany

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