530
Participants
Start Date
June 16, 2020
Primary Completion Date
June 30, 2029
Study Completion Date
December 31, 2029
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.
RECRUITING
Charité - Universitätsmedizin Berlin (CBF), Berlin
ACTIVE_NOT_RECRUITING
Charité - Universitätsmedizin Berlin (CVK, Berlin
RECRUITING
Cardiologicum Hamburg, Hamburg
RECRUITING
Asklepios Klinik Wandsbek, Hamburg
RECRUITING
Asklepios Klinik Nord Heidberg, Hamburg
RECRUITING
Asklepios Klinik Altona, Hamburg
RECRUITING
Universitätsklinikum Schleswig-Holstein (UKSH), Lübeck
RECRUITING
Evangelisches Klinikum Bethel, Bielefeld
ACTIVE_NOT_RECRUITING
Herz-Kreislauf-Zentrum, Rotenburg an der Fulda
ACTIVE_NOT_RECRUITING
Klinikum Dortmund, Dortmund
RECRUITING
Knappschaft Kliniken, Dortmund
RECRUITING
Katholisches Klinikum Koblenz • Montabaur, Koblenz
RECRUITING
Westpfalz-Klinikum, Kaiserslautern
RECRUITING
University Hospital Mannheim, Mannheim
RECRUITING
University Hospital Magdeburg, Magdeburg
ACTIVE_NOT_RECRUITING
RoMed Klinikum, Rosenheim
RECRUITING
Klinikum Ingolstadt, Ingolstadt
ACTIVE_NOT_RECRUITING
Therapiezentrum Burgau, Burgau
RECRUITING
Universitätsklinikum Erlangen, Erlangen
RECRUITING
REGIOMED Klinikum Coburg, Coburg
ACTIVE_NOT_RECRUITING
RHÖN-KLINIKUM Campus Bad Neustadt, Bad Neustadt an der Saale
RECRUITING
Helios Klinikum Erfurt, Erfurt
RECRUITING
Klinikum Chemnitz, Chemnitz
RECRUITING
Dresden Heart Center, Dresden
RECRUITING
University Hospital Leipzig, Leipzig
RECRUITING
Klinikum St. Georg, Leipzig
RECRUITING
Heart Center Leipzig, Leipzig
RECRUITING
Helios Klinikum Pirna, Pirna
RECRUITING
Heinrich-Braun-Klinikum (HBK), Zwickau
RECRUITING
University Hospital Jena, Jena
NOT_YET_RECRUITING
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan
NOT_YET_RECRUITING
Polsko-Amerykańskie Kliniki Serca, Bielsko-Biala
RECRUITING
Górnośląskim Centrum Medycznym, Katowice
Collaborators (1)
KCRI
OTHER
Jena University Hospital
OTHER