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New hope for AF patients: device may replace blood thinners after brain bleed

NCT ID NCT04298723

Recruiting now Disease control Sponsor: Jena University Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study tests whether closing a small pouch in the heart (the left atrial appendage) with a device is safer and as effective as long-term blood thinners for people with atrial fibrillation who have already had a brain bleed. About 530 participants will be randomly assigned to either the device procedure or continued blood thinner medication. The goal is to see which approach better prevents strokes, heart-related death, and serious bleeding.

What this could mean

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

Active substance
Watchman or Watchman FLX left atrial appendage closure device
What this could lead to
If successful, this could offer a safer alternative to long-term blood thinners for AF patients who have already had a brain bleed, reducing both stroke and bleeding risks.
What could go wrong
This is a mid-sized trial (530 participants) and the device procedure itself carries risks like bleeding, infection, or device complications. Results may not apply to all AF patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter intracerebral hemorrhage Intracranial Hemorrhages

As listed by the trial registrant

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

ATRIAL FIBRILLATION (AF) ATRIAL FLUTTER INTRACRANIAL HEMORRHAGES

Contacts and locations

Locations

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany

  • Asklepios Klinik Nord Heidberg

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22417, Germany

  • Asklepios Klinik Wandsbek

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22043, Germany

  • Cardiologicum Hamburg

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22041, Germany

  • Charité - Universitätsmedizin Berlin (CBF)

    RECRUITING

    Berlin, State of Berlin, 12203, Germany

  • Charité - Universitätsmedizin Berlin (CVK

    ACTIVE_NOT_RECRUITING

    Berlin, State of Berlin, 13353, Germany

  • Dresden Heart Center

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • GPR Gesundheits- und Pflegezentrum Rüsselsheim

    RECRUITING

    Rüsselsheim am Main, Hesse, 65428, Germany

  • Górnośląskim Centrum Medycznym

    RECRUITING

    Katowice, Silesian Voivodeship, 40-635, Poland

  • Heart Center Leipzig

    RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Heinrich-Braun-Klinikum (HBK)

    RECRUITING

    Zwickau, Saxony, 08060, Germany

  • Helios Klinikum Erfurt

    RECRUITING

    Erfurt, Thuringia, 99089, Germany

  • Helios Klinikum Pirna

    RECRUITING

    Pirna, Saxony, 01796, Germany

  • Herz-Kreislauf-Zentrum

    ACTIVE_NOT_RECRUITING

    Rotenburg an der Fulda, Hesse, 44137, Germany

  • Katholisches Klinikum Koblenz • Montabaur

    RECRUITING

    Koblenz, Rhineland-Palatinate, 56073, Germany

  • Katholisches Marienkrankenhaus gGmbH

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22087, Germany

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Saxony, 09113, Germany

  • Klinikum Dortmund

    ACTIVE_NOT_RECRUITING

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Klinikum Ingolstadt

    RECRUITING

    Ingolstadt, Bavaria, 85049, Germany

  • Klinikum St. Georg

    RECRUITING

    Leipzig, Saxony, 04129, Germany

  • Klinikum Vest GmbH Recklinghausen

    ACTIVE_NOT_RECRUITING

    Recklinghausen, North Rhine-Westphalia, 45657, Germany

  • Knappschaft Kliniken

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44309, Germany

  • Polsko-Amerykańskie Kliniki Serca

    NOT_YET_RECRUITING

    Bielsko-Biala, Silesian Voivodeship, 43-316, Poland

  • REGIOMED Klinikum Coburg

    RECRUITING

    Coburg, Bavaria, 96450, Germany

  • RHÖN-KLINIKUM Campus Bad Neustadt

    RECRUITING

    Bad Neustadt an der Saale, Bavaria, 97616, Germany

  • RoMed Klinikum

    ACTIVE_NOT_RECRUITING

    Rosenheim, Bavaria, 83022, Germany

  • Städtisches Klinikum Brandenburg GmbH

    RECRUITING

    Brandenburg an der Havel, Brandenburg, 14770, Germany

  • Therapiezentrum Burgau

    ACTIVE_NOT_RECRUITING

    Burgau, Bavaria, 89331, Germany

  • University Hospital Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • University Hospital Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • University Hospital Magdeburg

    RECRUITING

    Magdeburg, Saxony-Anhalt, 68167, Germany

  • University Hospital Mannheim

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Halle (Saale)

    ACTIVE_NOT_RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsklinikum der J.W. Goethe-Universität Frankfurt

    NOT_YET_RECRUITING

    Frankfurt am Main, Hesse, 60528, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    ACTIVE_NOT_RECRUITING

    Poznan, Greater Poland Voivodeship, 61-848, Poland

  • Westpfalz-Klinikum

    RECRUITING

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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