Intracranial HemorrhagesCLEARANCENCT04298723
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
A study testing Percutaneous closure of the LAA (Watchman / Watchman FLX) in people with Intracranial Hemorrhages and Atrial Fibrillation (AF), run by Jena University Hospital at 39 sites in 2 countries.
Trial summary
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages, Atrial Fibrillation (AF), Atrial Flutter
- What is being tested?
- Percutaneous closure of the LAA (Watchman / Watchman FLX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 16 Jun 2020to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
39 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 2 countries
Germany36 sites, 29 recruiting
- Recruiting
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
Hassan Soda, Dr., +4997716622356, Hassan.Soda@campus-nes.de
- Recruiting
Charité - Universitätsmedizin Berlin (CBF)
Berlin, State of Berlin, 12203
Carsten Skurk, Prof. Dr., +4930450513725, carsten.skurk@charite.de
- Active, not recruiting
Charité - Universitätsmedizin Berlin (CVK
Berlin, State of Berlin, 13353
- Recruiting
Evangelisches Klinikum Bethel
Bielefeld, North Rhine-Westphalia, 33617
Wladimir Tschichow, Dr., +4952177277672, Wladimir.Tschishow@evkb.de
- Recruiting
Städtisches Klinikum Brandenburg GmbH
Brandenburg an der Havel, Brandenburg, 14770
Oliver Ritter, Prof. Dr., +493381411500, o.ritter@uk-brandenburg.de
- Active, not recruiting
Therapiezentrum Burgau
Burgau, Bavaria, 89331
- Recruiting
Klinikum Chemnitz
Chemnitz, Saxony, 09113
Karim Ibrahim, Prof. Dr., +4937133342211, karim.ibrahim@skc.de
- Recruiting
REGIOMED Klinikum Coburg
Coburg, Bavaria, 96450
Steffen Schnupp, Dr., +4995612233201, steffen.schnupp@regiomed-kliniken.de
- Active, not recruiting
Klinikum Dortmund
Dortmund, North Rhine-Westphalia, 44137
- Recruiting
Knappschaft Kliniken
Dortmund, North Rhine-Westphalia, 44309
- Recruiting
Dresden Heart Center
Dresden, Saxony, 01307
Norman Mangner, Prof. Dr., +493514501701, norman.mangner@tu-dresden.de
- Recruiting
Helios Klinikum Erfurt
Erfurt, Thuringia, 99089
Frank Steinborn, Dr., +493617812481, frank.steinborn@helios-gesundheit.de
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Kosmas Macha, PD Dr., +4991318534306, Kosmas.Macha@uk-erlangen.de
- Not yet recruiting
Universitätsklinikum der J.W. Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60528
Christian Grefkes-Hermann, Prof. Dr., +496963015769, neurologie-direktor@unimedizin-ffm.de
- Active, not recruiting
Universitätsklinikum Halle (Saale)
Halle, Saxony-Anhalt, 06120
- Recruiting
Cardiologicum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22041
Martin Bergmann, Prof. Dr., +49401818811221, mar.bergmann@asklepios.com
- Recruiting
Asklepios Klinik Wandsbek
Hamburg, Free and Hanseatic City of Hamburg, 22043
Tudor C Pörner, PD Dr., +49401818831051, t.poerner@asklepios.com
- Recruiting
Katholisches Marienkrankenhaus gGmbH
Hamburg, Free and Hanseatic City of Hamburg, 22087
Jury Schewel, PD Dr., +494025462945, j.schewel@marienkrankenhaus.org
- Recruiting
Asklepios Klinik Nord Heidberg
Hamburg, Free and Hanseatic City of Hamburg, 22417
Alexander Ghanem, Prof. Dr., +49401818873286, a.ghanem@asklepios.com
- Recruiting
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, 22763
Felix Meincke, Dr., +49401818818902, f.meincke@asklepios.com
- Recruiting
Klinikum Ingolstadt
Ingolstadt, Bavaria, 85049
Blerim Luani, PD Dr., +498418802101, blerim.luani@klinikum-ingolstadt.de
- Recruiting
University Hospital Jena
Jena, Thuringia, 07747
Sven Möbius-Winkler, Prof. Dr., +4936419324503, Sven.Moebius-Winkler@med.uni-jena.de
Sissy Grund, sissy.grund@med.uni-jena.de
- Recruiting
Westpfalz-Klinikum
Kaiserslautern, Rhineland-Palatinate, 67655
Burghard Schumacher, Prof. Dr., +496312031255, bschumacher@westpfalz-klinikum.de
- Recruiting
Katholisches Klinikum Koblenz • Montabaur
Koblenz, Rhineland-Palatinate, 56073
Jiangtao Yu, PD Dr., +492614963132, j.yu@kk-km.de
- Recruiting
University Hospital Leipzig
Leipzig, Saxony, 04103
Karsten Lenk, PD Dr., +493419720956, Karsten.Lenk@medizin.uni-leipzig.de
- Recruiting
Klinikum St. Georg
Leipzig, Saxony, 04129
Norbert Klein, PD Dr., +493419092300, norbert.klein@sanktgeorg.de
- Recruiting
Heart Center Leipzig
Leipzig, Saxony, 04289
Marcus Sandri, PD Dr., +49341865252035, marcus.sandri@medizin.uni-leipzig.de
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, Schleswig-Holstein, 23538
Ingo Eitel, Prof. Dr., +4945150044504, Ingo.Eitel@uksh.de
- Recruiting
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 68167
Rüdiger Braun-Dullaeus, Prof. Dr., +493916713203, r.braun-dullaeus@med.ovgu.de
- Recruiting
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, 68167
Ibrahim Akin, Prof. Dr., +496213835229, ibrahim.akin@umm.de
- Recruiting
Helios Klinikum Pirna
Pirna, Saxony, 01796
Steffen Schön, Prof. Dr., +49350171185211, Steffen.Schoen@helios-gesundheit.de
- Active, not recruiting
Klinikum Vest GmbH Recklinghausen
Recklinghausen, North Rhine-Westphalia, 45657
- Active, not recruiting
RoMed Klinikum
Rosenheim, Bavaria, 83022
- Active, not recruiting
Herz-Kreislauf-Zentrum
Rotenburg an der Fulda, Hesse, 44137
- Recruiting
GPR Gesundheits- und Pflegezentrum Rüsselsheim
Rüsselsheim am Main, Hesse, 65428
Oliver Koeth, PD Dr., +496142881331, Oliver.Koeth@gp-ruesselsheim.de
- Recruiting
Heinrich-Braun-Klinikum (HBK)
Zwickau, Saxony, 08060
Holger H Sigusch, PD Dr., +49375512219, holger.sigusch@hbk-zwickau.de
Poland3 sites, 2 recruiting
- Not yet recruiting
Polsko-Amerykańskie Kliniki Serca
Bielsko-Biala, Silesian Voivodeship, 43-316
Krzysztof Milewski, Prof. Dr., Krzysztof.Milewski@ahop.pl
- Recruiting
Górnośląskim Centrum Medycznym
Katowice, Silesian Voivodeship, 40-635
Wojciech Wojakowski, Prof. Dr., +48604188669, w.wojakowski@sum.edu.pl
- Active, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, 61-848
About this study
Official title: Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.
Read the detailed description
Within the current trial, two novel strategies are tested in a randomized fashion in patients with atrial fibrillation and status post intracranial bleeding. Patients with ICH were usually excluded from the large NOAC trials and were also not representatively included in the large Watchman device trials. On the other hand, registries show that there is a significant proportion of patients with status post ICH that were implanted with a LAA closure device in clinical routine, and also there are those patients treated with NOAC due to their high stroke risk, despite the risk of recurrent ICH.
Both therapies, NOAC and LAA closure are effective in preventing stroke in patients with AF at high risk for stroke. Also, for both therapies there is evidence for prevention of bleedings, especially intracranial bleeding events.
Patients within the LAA closure group will have the chance after successful closure of the LAA to quit oral anticoagulation medication and therefore reduce their lifetime risk for bleeding and recurrent bleeding. Patients in the NOAC group are provided with an excellent protection against stroke and a significant reduced bleeding risk compared to Vitamin K antagonist therapy.
The trial will help to develop data and hopefully guidelines for management of patients with AF and status post intracranial bleedings. It may help to give physicians data to therapy patients post ICH adequately and help to reduce mortality rates in those patients.
- Being tested
- Percutaneous closure of the LAA (Watchman / Watchman FLX)
- Keywords
- Intracranial Hemorrhage, Intracranial Bleeding, Atrial Fibrillation, Anticoagulation, LAA Occlusion
- Medical subject headings
- Intracranial Hemorrhages, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous closure of the LAA (Watchman / Watchman FLX)Device
LAA closure procedure will be done by experienced operators according to the local SOP. LAA closure will be performed under fluoroscopic and TEE guidance within conscious sedation or general anesthesia. Antibiotic single-shot prophylaxis should be administered peri-procedurally (i.e., cefazolin 2 g). The specific anatomy of the LAA is evaluated and an appropriately sized CE-marked device (Watchman or Watchman FLX) is deployed. LAA angiography and TEE imaging is performed to identify optimal positioning of the device and to exclude a relevant leak. Following device deployment, patients will receive a therapy according to the manufacturers IFU, currently Aspirin and clopidogrel for 3 months followed by single Aspirin up to 12 months. Alternatively, 3 months of NOAC followed by Aspirin monotherapy up to 12 months are possible.
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Appendage Occlusion | Experimental | Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX Receives: Device: Percutaneous closure of the LAA (Watchman / Watchman FLX) |
| Best Medical Therapy for Anticoagulation | No intervention | Standard of care (according to current guidelines) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Cardiovascular or unexplained death
Cardiovascular mortality:
- Death due to proximate cardiac cause e.g. myocardial infarction, cardiac tamponade, worsening heart failure, or endocarditis
- Death caused by non-coronary, non-CNS vascular conditions such as: pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm or other vascular disease
- Death from vascular CNS causes from hemorrhagic and ischemic stroke
- All procedure-related deaths including those related to a complication of the procedure or treatment for a complication of the procedure
- Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within one hour of the onset of symptoms in an apparently healthy subject. If death is not witness, the definition applies when the victim was in good health 24 hours before the event
- Death of unknown cause
Measured: up to 3 years after randomization
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Stroke (including ischemic or hemorrhagic stroke) - A stroke is an acute episode (lasting >24 hours) of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Strokes are characterized as follows:
- Ischemic stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
- Hemorrhagic stroke: an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Measured: up to 3 years after randomization
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Systemic embolism - Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Measured: up to 3 years after randomization
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Bleeding (BARC type 2-5) - Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
- Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
- Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
- Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
- Probable fatal bleeding
- Definite fatal bleeding (overt or autopsy or imaging confirmation)
Measured: up to 3 years after randomization
Secondary outcomes (10)
Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year
Primary endpoint events per year: Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year; The study participants or, if consent has been obtained, relatives are questioned during the visits, if necessary, diagnostic results are obtained;
Measured: up to 3 years after randomization
Combined endpoint: MACCE
Combined endpoint: MACCE (stroke/systemic embolism/cardiovascular death/myocardial infarction)
Measured: up to 3 years after randomization
Mortality
Mortality (including all-cause death, cardiovascular death, non- cardiovascular
Measured: up to 3 years after randomization
Bleeding (BARC type 2-5)
Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
- Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
- Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
- Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
- Probable fatal bleeding
- Definite fatal bleeding (overt or autopsy or imaging confirmation)
Measured: up to 3 years after randomization
Systemic embolism
Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Measured: up to 3 years after randomization
Ischemic stroke
An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Measured: up to 3 years after randomization
Hemorrhagic stroke
An acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Measured: up to 3 years after randomization
Myocardial infarction
A detailed description of the criteria for myocardial infarction can be found in the study protocol.
Measured: up to 3 years after randomization
Hospitalization for bleeding or cardiovascular event
Hospitalization for bleeding or cardiovascular event
Measured: up to 3 years after randomization
Intracranial bleeding
Intracranial bleeding
Measured: up to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start16 Jun 2020
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, prospective, randomized, controlled, non-blinded clinical trial with a two-arm parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Principal investigator, Sven Möbius-Winkler, Jena University Hospital
- Investigators
- Sven Möbius-Winkler, Prof. Dr., Principal investigator, Department of Internal Medicine I, Jena University HospitalAlbrecht Günther, Dr., Principal investigator, Department of Neurology, Jena University HospitalChristian Senft, Prof. Dr., Principal investigator, Department of Neurosurgery, Jena University HospitalP. Christian Schulze, Prof. Dr., Principal investigator, Department of Internal Medicine I, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298723
- Sponsor's protocol ID
- ZKSJ0123_CLEARANCE
- Acronym
- CLEARANCE
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2020
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.
- ClinicalTrials.gov ID
- NCT04298723
- Acronym / sponsor ID
- CLEARANCE / ZKSJ0123_CLEARANCE
- Keywords
- Intracranial Hemorrhage, Intracranial Bleeding, Atrial Fibrillation, Anticoagulation, LAA Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.
Detailed description
Within the current trial, two novel strategies are tested in a randomized fashion in patients with atrial fibrillation and status post intracranial bleeding. Patients with ICH were usually excluded from the large NOAC trials and were also not representatively included in the large Watchman device trials. On the other hand, registries show that there is a significant proportion of patients with status post ICH that were implanted with a LAA closure device in clinical routine, and also there are those patients treated with NOAC due to their high stroke risk, despite the risk of recurrent ICH.
Both therapies, NOAC and LAA closure are effective in preventing stroke in patients with AF at high risk for stroke. Also, for both therapies there is evidence for prevention of bleedings, especially intracranial bleeding events.
Patients within the LAA closure group will have the chance after successful closure of the LAA to quit oral anticoagulation medication and therefore reduce their lifetime risk for bleeding and recurrent bleeding. Patients in the NOAC group are provided with an excellent protection against stroke and a significant reduced bleeding risk compared to Vitamin K antagonist therapy.
The trial will help to develop data and hopefully guidelines for management of patients with AF and status post intracranial bleedings. It may help to give physicians data to therapy patients post ICH adequately and help to reduce mortality rates in those patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, prospective, randomized, controlled, non-blinded clinical trial with a two-arm parallel group design
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Appendage Occlusion | Experimental | Device: Percutaneous closure of the LAA (Watchman / Watchman FLX)Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX |
| Best Medical Therapy for Anticoagulation | No intervention | –Standard of care (according to current guidelines) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous closure of the LAA (Watchman / Watchman FLX)LAA closure procedure will be done by experienced operators according to the local SOP. LAA closure will be performed under fluoroscopic and TEE guidance within conscious sedation or general anesthesia. Antibiotic single-shot prophylaxis should be administered peri-procedurally (i.e., cefazolin 2 g). The specific anatomy of the LAA is evaluated and an appropriately sized CE-marked device (Watchman or Watchman FLX) is deployed. LAA angiography and TEE imaging is performed to identify optimal positioning of the device and to exclude a relevant leak. Following device deployment, patients will receive a therapy according to the manufacturers IFU, currently Aspirin and clopidogrel for 3 months followed by single Aspirin up to 12 months. Alternatively, 3 months of NOAC followed by Aspirin monotherapy up to 12 months are possible. | Device | Left Atrial Appendage Occlusion |
Primary outcome
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Time frame: up to 3 years after randomization
Cardiovascular or unexplained death Cardiovascular mortality: * Death due to proximate cardiac cause e.g. myocardial infarction, cardiac tamponade, worsening heart failure, or endocarditis * Death caused by non-coronary, non-CNS vascular conditions such as: pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm or other vascular disease * Death from vascular CNS causes from hemorrhagic and ischemic stroke * All procedure-related deaths including those related to a complication of the procedure or treatment for a complication of the procedure * Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within one hour of the onset of symptoms in an apparently healthy subject. If death is not witness, the definition applies when the victim was in good health 24 hours before the event * Death of unknown cause
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Time frame: up to 3 years after randomization
Stroke (including ischemic or hemorrhagic stroke) - A stroke is an acute episode (lasting >24 hours) of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Strokes are characterized as follows: * Ischemic stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke. * Hemorrhagic stroke: an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Time frame: up to 3 years after randomization
Systemic embolism - Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5)
Time frame: up to 3 years after randomization
Bleeding (BARC type 2-5) - Type 2 Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional Type 3 1. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding 2. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 4 CABG-related bleeding within 48 hours Type 5 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation)
10 secondary outcomes
Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year
Time frame: up to 3 years after randomization
Combined endpoint: MACCE
Time frame: up to 3 years after randomization
Mortality
Time frame: up to 3 years after randomization
Bleeding (BARC type 2-5)
Time frame: up to 3 years after randomization
Systemic embolism
Time frame: up to 3 years after randomization
Ischemic stroke
Time frame: up to 3 years after randomization
Hemorrhagic stroke
Time frame: up to 3 years after randomization
Myocardial infarction
Time frame: up to 3 years after randomization
Hospitalization for bleeding or cardiovascular event
Time frame: up to 3 years after randomization
Intracranial bleeding
Time frame: up to 3 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sven Möbius-Winkler, Prof. Dr. principal investigator
Department of Internal Medicine I, Jena University Hospital
Albrecht Günther, Dr. principal investigator
Department of Neurology, Jena University Hospital
Christian Senft, Prof. Dr. principal investigator
Department of Neurosurgery, Jena University Hospital
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous closure of the LAA (Watchman / Watchman FLX) in people with Intracranial Hemorrhages and Atrial Fibrillation (AF), run by Jena University Hospital at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Möbius-Winkler, Prof. Dr. (+4936419324503, sven.moebius-winkler@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival of the composite of cardiovascular or unexplained death, stroke (including ischemic or hemorrhagic stroke), systemic embolism, bleeding (BARC type 2-5) (time frame: up to 3 years after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.