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ER heart fix: can ablation right away stop AFib recurrence?

NCT ID NCT05294445

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether doing a heart procedure called cryoablation right away in the emergency room can help people with recent atrial fibrillation (AFib). About 350 adults with AFib that started within the past year will be randomly assigned to get either immediate ablation or standard care. The main goal is to see if the ablation group has fewer episodes of irregular heart rhythms over the next 12 months.

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

350 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 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: * Documented, paroxysmal or persistent AF (longest AF episode \< 6-month duration). Any ECG documentation of AF (12 lead ECG, Holter ECG or mobile ECG monitoring) needs to be presented. * Recent-onset AF (≤ 1 year prior to enrolment) * Presenting at the emergency department or outpatient clinic within the last 2 weeks because of AF, including patients with spontaneous conversion in sinus rhythm (with prior AF documentation) * Age ≥ 18 years * Subject is able and willing to give informed consent Exclusion Criteria * Pers. AF \> 6 Mon (one episode) * LA-Diameter \> 60mm * Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement * Any previous left atrial 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. * Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator * Any condition or disease, which is a contraindication for antiarrhythmic drug treatment, up to the assessment of the investigator * Known intra-cardiac thrombus formation under continuous oral anticoagulation (defined as intake \>4 weeks) * Any contraindication for oral anticoagulation * Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism * Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control * Active systemic infection * Co-Existence of non PV-dependent atrial Tachycardia * Indication for implantation of ICD or pacemaker

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF)

Contacts and locations

Locations

  • AK Altona

    Hamburg, 22763, Germany

  • AK Nord

    Hamburg-Nord, 22417, Germany

  • Asklepios Klinik Harburg

    Harburg, 21075, Germany

  • Asklepios Klinik St. Georg

    Hamburg, 20099, Germany

  • Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus

    Frankfurt, 60431, Germany

  • Deutsches Herzzentrum der Charité

    Berlin, 13353, Germany

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217, Germany

  • Herzzentrum Uniklinik Köln

    Cologne, 50937, Germany

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, 61231, Germany

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, 65189, Germany

  • Universitäres Herz- und Gefäßzentrum

    Hamburg, 20246, Germany

  • Universitätsklinikum Giessen

    Giessen, 35392, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

More trials for these conditions

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