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New hope for stroke survivors: closing a heart pouch may cut stroke risk

NCT ID NCT05976685

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This study tests whether closing a small pouch in the heart (left atrial appendage) with a device, along with blood thinners, can prevent another stroke better than blood thinners alone. It includes 482 adults with atrial fibrillation who had a recent stroke despite taking anticoagulants. Participants are randomly assigned to get the procedure plus blood thinners or just blood thinners, and are followed for up to 4 years.

What this could mean

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

Active substance
Left atrial appendage occlusion (a procedure to close a heart pouch) plus direct oral anticoagulants (blood thinners)
What this could lead to
If it works, this could offer a new way to reduce the risk of another stroke in people with atrial fibrillation who still have strokes despite taking blood thinners.
What could go wrong
This is a mid-sized trial, and the procedure carries risks like bleeding or device complications. It may not prove superior to blood thinners alone, and results may not apply to all patients.

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 482 people

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

Started

May 2024

Expected to finish

Jun 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: * Age ≥ 18 years * Written informed consent * Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization. * Recent (≤3 months) symptomatic ischemic stroke. * Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \[Vitamin K antagonist/DOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\] not stopped/paused for \>48 hours due to any reason, i.e. medical intervention or non-adherence). * Active or planned long-term therapy with DOAC Exclusion Criteria: * Contraindications to DOAC therapy * Life expectancy \<1 year according to the opinion of the investigator * Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \[RCVS\], Posterior Reversible Encephalopathy Syndrome \[PRES\], cerebral sinus venous thrombosis) * Previous persistent foramen ovale or atrial septum defect closure. * Rheumatic heart disease * Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation). * Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer). * Cardiac or non-cardiac surgical procedure within 30 days of randomization * Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy. * Severely reduced Left Ventricular Ejection Fraction (LVEF) \<30%. * Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \<15 ml/min; dabigatran creatinine clearance \<30 ml/min). * Hypertrophic cardiomyopathy * Intracardiac tumor * Ventricular thrombus * Acute cardiac decompensation * LAA is obliterated or surgically ligated * Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO) * Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation ischemic stroke stroke disorder

As listed by the trial registrant

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

Atrial fibrillation Ischemic stroke

How to take part

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

  1. The places running it

    32 sites in 6 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

  • AZ Sint Jan Brugge

    RECRUITING

    Bruges, 8000, Belgium

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Brussels University Hospital

    RECRUITING

    Brussels, 1090, Belgium

  • CHU Liège Sart-Tilman

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire Vaudois

    RECRUITING

    Lausanne, Vaude, 1011, Switzerland

  • Charing Cross Hospital

    RECRUITING

    London, United Kingdom

  • Charité-Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Christchurch Hospital

    RECRUITING

    Christchurch, 8011, New Zealand

  • Ente Ospedaliero Cantonale

    RECRUITING

    Lugano, Canton Ticino, 6900, Switzerland

  • HUmani CHU Charleroi-Chimay

    RECRUITING

    Charleroi, 6000, Belgium

  • Hosp. Barcelona Santa Creu y Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hosp. Clínic of Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hosp. General Universario Dr. Balmis de Alicante

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Clínico San Carlos (HCSC)

    RECRUITING

    Madrid, 28040, Spain

  • Hôpitaux universitaires de Genève

    NOT_YET_RECRUITING

    Geneva, 1211, Switzerland

  • Inselspital, University Hospital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Luzerner Kantonsspital

    NOT_YET_RECRUITING

    Lucerne, 6000, Switzerland

  • St Bartholomew's Hospital

    RECRUITING

    London, United Kingdom

  • St Thomas' Hospital

    RECRUITING

    London, United Kingdom

  • UCLouvain - Cliniques universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • UKSH, Campus Lübeck

    RECRUITING

    Lübeck, Schleswig-Holstein, 26538, Germany

  • Universitair Ziekenhuis (UZ) Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • University Hospitals Sessex NHS Trust

    RECRUITING

    Worthing, United Kingdom

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsmedizin Göttingen

    RECRUITING

    Göttingen, 37075, Germany

  • Universitätsmedizin Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

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