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

NCT ID NCT04298723

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Asklepios Klinik Altona

    RECRUITING

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

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Asklepios Klinik Nord Heidberg

    RECRUITING

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

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Asklepios Klinik Wandsbek

    RECRUITING

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

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Cardiologicum Hamburg

    RECRUITING

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

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Charité - Universitätsmedizin Berlin (CBF)

    RECRUITING

    Berlin, State of Berlin, 12203, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Charité - Universitätsmedizin Berlin (CVK

    ACTIVE_NOT_RECRUITING

    Berlin, State of Berlin, 13353, Germany

  • Dresden Heart Center

    RECRUITING

    Dresden, Saxony, 01307, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33617, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Górnośląskim Centrum Medycznym

    RECRUITING

    Katowice, Silesian Voivodeship, 40-635, Poland

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Heart Center Leipzig

    RECRUITING

    Leipzig, Saxony, 04289, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Heinrich-Braun-Klinikum (HBK)

    RECRUITING

    Zwickau, Saxony, 08060, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Helios Klinikum Erfurt

    RECRUITING

    Erfurt, Thuringia, 99089, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Helios Klinikum Pirna

    RECRUITING

    Pirna, Saxony, 01796, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Herz-Kreislauf-Zentrum

    ACTIVE_NOT_RECRUITING

    Rotenburg an der Fulda, Hesse, 44137, Germany

  • Katholisches Klinikum Koblenz • Montabaur

    RECRUITING

    Koblenz, Rhineland-Palatinate, 56073, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Saxony, 09113, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Klinikum Dortmund

    ACTIVE_NOT_RECRUITING

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Klinikum Ingolstadt

    RECRUITING

    Ingolstadt, Bavaria, 85049, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Klinikum St. Georg

    RECRUITING

    Leipzig, Saxony, 04129, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Knappschaft Kliniken

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44309, Germany

  • Polsko-Amerykańskie Kliniki Serca

    NOT_YET_RECRUITING

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

    Contact Email: •••••@•••••

  • REGIOMED Klinikum Coburg

    RECRUITING

    Coburg, Bavaria, 96450, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • RHÖN-KLINIKUM Campus Bad Neustadt

    ACTIVE_NOT_RECRUITING

    Bad Neustadt an der Saale, Bavaria, 97616, Germany

  • RoMed Klinikum

    ACTIVE_NOT_RECRUITING

    Rosenheim, Bavaria, 83022, Germany

  • Therapiezentrum Burgau

    ACTIVE_NOT_RECRUITING

    Burgau, Bavaria, 89331, Germany

  • University Hospital Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University Hospital Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University Hospital Magdeburg

    RECRUITING

    Magdeburg, Saxony-Anhalt, 68167, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University Hospital Mannheim

    RECRUITING

    Mannheim, Baden-Wurttemberg, 68167, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    NOT_YET_RECRUITING

    Poznan, Greater Poland Voivodeship, 61-848, Poland

    Contact Email: •••••@•••••

  • Westpfalz-Klinikum

    RECRUITING

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

    Contact Phone: •••-•••-•••• Email: •••••@•••••