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Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Sponsor: Jena University Hospital
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. 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.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
530
Start Date
2020-06-16
Completion Date
2029-12
Last Updated
2025-09-02
Healthy Volunteers
No
Interventions
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.
Locations (33)
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, Hamburg, Germany
Asklepios Klinik Wandsbek
Hamburg, Hamburg, Germany
Asklepios Klinik Nord Heidberg
Hamburg, Hamburg, Germany
Asklepios Klinik Altona
Hamburg, 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