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Heart pouch procedure may beat blood thinners for stroke prevention

NCT ID NCT03463317

Disease control Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a procedure to close a small pouch in the heart (left atrial appendage) in people with atrial fibrillation who are at high risk for both stroke and bleeding. The goal was to see if this procedure works better than standard blood-thinning medications at preventing strokes, major bleeds, or death. Over 900 participants were randomly assigned to either the closure procedure or best medical therapy.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

912 people

The number who actually took part.

Started

Feb 2018

Finished

Nov 2024

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: * Signed written informed consent * Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent) * CHA2DS2VASc-Score ≥2 * High risk of bleeding under oral anticoagulation or contraindication for (N)OAC therapy, in particular patients with at least one of the following conditions: * HAS-BLED-Score ≥3 * Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c) * Hemorrhagic/bleeding complication fulfilling BARC type 3a or 3b: gastrointestinal tract, genitourinary tract or respiratory tract bleeding, where the patient is considered to be at a persistently increased risk of bleeding, e.g. the cause of bleeding cannot be successfully eliminated * Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2 * Any recurrent bleeding making chronic anticoagulation not feasible * Subject eligible for an LAA occluder device * Age ≥18 years * Willing and capable of providing informed consent, participating in all associated study activities * negative SARS-CoV-2 PCR test (no longer than 48 hours prior to randomization in outpatients or not older than 14 days in continuously hospitalized patients without signs of COVID-19 infection) or negative SARS- CoV-2 rapid antigen test (no longer than 24 hours prior to randomization) Exclusion Criteria: * Absolute contraindication to acetylsalicylic acid * Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis * Symptomatic carotid disease (if not treated) * Complex aortic atheroma with mobile plaque (Kronzon classification grade V) * Heart transplant * Active infection or symptoms suggestive of COVID-19 infection or active endocarditis or other infections resulting in bacteremia * Cardiac tumor * Severe liver failure (Child-Pugh class C or liver failure with coagulopathy) * Severe renal failure (GFR \<15 ml/min/1.73m2 or current requirement for dialysis defined as current, regular renal replacement therapy performed at least weekly including hemodialysis and peritoneal dialysis within the last 30 days) * Pregnancy or breastfeeding * For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index \<1) throughout the study period * Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial. * Known terminating disease with life expectancy \<1 year (including those with end-stage heart failure) * Subjects, who are committed to an institution due to binding official or court order * Subject who is dependent on the Site, the Site Investigator, any sub- investigator, his/her representative and/or the sponsor * Persons who are not proficient in the German language * Unstable/not fully recompensated acute heart failure corresponding to NYHA class III and/or IV * Subjects with known antiphospholipid syndrome * Subjects with planned cardiac or non-cardiac surgery or intervention. (These subject can be included 30 days after such intervention / surgery.)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Amper Kliniken AG, Helios Amper-Klinikum Dachau, Innere Medizin I - Kardiologie & Pneumologie

    Dachau, Germany

  • Asklepios Klinik Barmbek, I. Med. Abteilung - Kardiologie

    Hamburg, 22291, Germany

  • Asklepios Klinik St. Georg Hamburg, Abteilung für Kardiologie

    Hamburg, Germany

  • Cardiologicum Hamburg

    Hamburg, Germany

  • Charité Universitätsmedizin Berlin, Campus Charité Mitte, Med. Klinik für Kardiologie und Angiologie

    Berlin, Germany

  • Charité Universitätsmedizin Berlin, Klinik für Kardiologie, Angiologie und Intensivmedizin, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin (CBF)

    Berlin, 12203, Germany

  • DRK-Kliniken Berlin Köpenick, Klinik für Innere Medizin - Schwerpunkt Kardiologie und Angiologie

    Berlin, 12559, Germany

  • Deutsches Herzzentrum München, Klinik an der TU München

    München, 80636, Germany

  • Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin, Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Gesundheit Nord gGmbH, Klinikum Links der Weser, Klinik für Kardiologie und Angiologie

    Bremen, 28277, Germany

  • HELIOS Klinikum Erfurt GmbH, 3. Medizinische Klinik

    Erfurt, Germany

  • Heinrich-Braun-Klinikum Zwickau, Klinik für Innere Medizin I - Kardiologie, Angiologie, Intern. Internsivmedizin

    Zwickau, 08060, Germany

  • Herzzentrum Leipzig, Universitätsklinik für Kardiologie

    Leipzig, Germany

  • Katholisches Krankenhaus "St. Johann Nepomuk", Klinik für Innere Medizin II - Kardiologie

    Erfurt, 99097, Germany

  • Klinik für Kardiologie, Angiologie und Intensivmedizin, Deutsches Herzzentrum der Charité, Campus Virchow-Klinikum (CVK)

    Berlin, 13353, Germany

  • Klinikum Brandenburg GmbH, Zentrum für Innere Medizin I

    Brandenburg, 14770, Germany

  • Klinikum Coburg GmbH II. Med. Klinik für Innere Medizin und Kardiologie

    Coburg, Germany

  • Klinikum rechts der Isar, TU München, Klinik und Poliklinik für Innere Medizin I - Kardiologie

    München, Germany

  • LMU Universität München, Medizinische Klinik und Poliklinik I

    München, 81377, Germany

  • Oberhavel Kliniken, Klinik Hennigsdorf, Innere Medizin

    Hennigsdorf, Germany

  • Peter Osypka Herzzentrum München

    München, 81379, Germany

  • Städt. Klinikum München GmbH, Klinikum Neuperlach, Klinik für Kardiologie, Pneumologie, intern. Intensivmedizin

    München, 81737, Germany

  • Städtisches Klinikum Dresden, II. Medizinische Klinik

    Dresden, Germany

  • Technische Universität Dresden, Herzzentrum Dresden, Universitätsklinik, Medizinische Klinik Kardiologie

    Dresden, Germany

  • UHZ Freiburg Bad Krozingen Klinik für Kardiologie und Angiologie II

    Freiburg im Breisgau, Germany

  • UKSH - Campus Kiel, Medizinische Klinik III - Kardiologie, Angiologie, Intensivmedizin

    Kiel, 24105, Germany

  • UKSH - Universitäres Herzzentrum Lübeck, Medizinische Klinik II - Kardiologie, Angiologie, Intensivmedizin

    Lübeck, 23538, Germany

  • Universität Greifswald, Klinik für Innere Medizin B - Kardiologie

    Greifswald, 17475, Germany

  • Universitätsklinik Ulm, Klinik für Innere Medizin II - Kardiologie

    Ulm, 89081, Germany

  • Universitätsklinikum Frankfurt, Medizinische Klinik III/ Kardiologie

    Frankfurt, Germany

  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin III

    Halle, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Universitäres Herzzentrum, Klinik für Allgemeine und Interventionelle Kardiologie

    Hamburg, Germany

  • Universitätsklinikum Heidelberg, Medizinische Klinik für Kardiologie, Angiologie und Pneumologie

    Heidelberg, Germany

  • Universitätsklinikum Jena, Klinik für Innere Medizin I - Kardiologie

    Jena, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

    Leipzig, Germany

  • Universitätsklinikum Tübingen, Medizinische Klinik, Abteilung III Kardiologie und Kreislauferkrankungen

    Tübingen, Germany

  • Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I

    Würzburg, Germany

  • Universitätsmedizin Göttingen, Klinik für Kardiologie und Pneumologie

    Göttingen, Germany

  • Universitätsmedizin Mainz, Kardiologie I - Zentrum für Kardiologie

    Mainz, 55131, Germany

  • Universitätsmedizin Mannheim, I. Medizinische Klinik - Kardiologie, Angiologie, Intensivmedizin

    Mannheim, 68167, Germany

  • Universitätsmedizin Rostock, Herzzentrum, Zentrum Innere Medizin - Abteilung für Kardiologie

    Rostock, Germany

  • Westküstenklinikum Heide Medizinische Klinik 2 - Kardiologie

    Heide, Germany

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