Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
NCT ID: NCT04298723
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
530 participants
INTERVENTIONAL
2020-06-16
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Left Atrial Appendage Occlusion
Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX
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.
Best Medical Therapy for Anticoagulation
Standard of care (according to current guidelines)
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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KCRI
OTHER
Jena University Hospital
OTHER
Responsible Party
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Sven Möbius-Winkler
Principal Investigator, Debuty director cardiology departement
Principal Investigators
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Sven Möbius-Winkler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine I, Jena University Hospital
Albrecht Günther, Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Jena University Hospital
Christian Senft, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Jena University Hospital
P. Christian Schulze, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine I, Jena University Hospital
Locations
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University Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
Therapiezentrum Burgau
Burgau, Bavaria, Germany
REGIOMED Klinikum Coburg
Coburg, Bavaria, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum Ingolstadt
Ingolstadt, Bavaria, Germany
RoMed Klinikum
Rosenheim, Bavaria, Germany
Cardiologicum Hamburg
Hamburg, City state of Hamburg, Germany
Asklepios Klinik Wandsbek
Hamburg, City state of Hamburg, Germany
Asklepios Klinik Nord Heidberg
Hamburg, City state of Hamburg, Germany
Asklepios Klinik Altona
Hamburg, City state of Hamburg, Germany
Herz-Kreislauf-Zentrum
Rotenburg an der Fulda, Hesse, Germany
Evangelisches Klinikum Bethel
Bielefeld, North Rhine-Westphalia, Germany
Klinikum Dortmund
Dortmund, North Rhine-Westphalia, Germany
Knappschaft Kliniken
Dortmund, North Rhine-Westphalia, Germany
Westpfalz-Klinikum
Kaiserslautern, Rhineland-Palatinate, Germany
Katholisches Klinikum Koblenz • Montabaur
Koblenz, Rhineland-Palatinate, Germany
Klinikum Chemnitz
Chemnitz, Saxony, Germany
Dresden Heart Center
Dresden, Saxony, Germany
University Hospital Leipzig
Leipzig, Saxony, Germany
Klinikum St. Georg
Leipzig, Saxony, Germany
Heart Center Leipzig
Leipzig, Saxony, Germany
Helios Klinikum Pirna
Pirna, Saxony, Germany
Heinrich-Braun-Klinikum (HBK)
Zwickau, Saxony, Germany
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, Schleswig-Holstein, Germany
Charité - Universitätsmedizin Berlin (CBF)
Berlin, State of Berlin, Germany
Charité - Universitätsmedizin Berlin (CVK
Berlin, State of Berlin, Germany
Helios Klinikum Erfurt
Erfurt, Thuringia, Germany
University Hospital Jena
Jena, Thuringia, Germany
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Polsko-Amerykańskie Kliniki Serca
Bielsko-Biala, Silesian Voivodeship, Poland
Górnośląskim Centrum Medycznym
Katowice, Silesian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZKSJ0123_Clearance
Identifier Type: -
Identifier Source: org_study_id
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