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

NCT ID NCT04298723

Disease control Sponsor: Jena University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 530 people

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

Started

Jun 2020

Expected to finish

Dec 2029

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: * Signed written informed consent * Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent) * CHA2DS2VASc-Score ≥2 * Status post intracranial bleeding \>6 weeks * Favorable LAA anatomy * Subject eligible for a LAA occluder device * Age ≥18 years Exclusion Criteria: * Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis * Symptomatic carotid disease (if not treated) * Thrombus in the left atrium or left atrial appendage * Active infection or active endocarditis or other infections resulting in bacteremia * Functional Impairment (modified ranking scale ≥4 ) * Severe liver failure (Child-Pugh class C or liver failure with coagulopathy) * Pregnancy or breastfeeding * 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 * Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention / surgery

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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

How to take part

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

  1. The places running it

    31 sites in 2 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

  • 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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