3,595
Participants
Start Date
November 16, 2023
Primary Completion Date
November 30, 2027
Study Completion Date
November 30, 2027
Implantable cardioverter-defibrillator (ICD)
"A transvenous ICD consists of an electronic medical device and electrode leads. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing).~The subcutaneous defibrillator is an established and valid alternative to the transvenous ICD for the prevention of SCD, but in patients without an indication for bradycardia support, cardiac resynchronisation or antitachycardia pacing.~The extravascular implantable cardioverter-defibrillator (EV ICD) system with substernal lead placement is a novel nontransvenous alternative to current available transvenous and subcutaneous ICDs."
Optimal Medical Therapy (OMT)
"Patients will be treated according to Optimal Medical Therapy defined by the following guidelines:~1. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes~2. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure"
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Semmelweis University, Budapest
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Amsterdam UMC, Amsterdam
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Universitätsklinikum Wiener Neustadt, Wiener Neustadt
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Universitätsklinikum St. Pölten, Sankt Pölten
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Centre hospitaliser régional (CHR) de la Citadelle, Liège
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Ordensklinikum Linz GmbH Elisabethinen, Linz
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Klinikum Wels-Grieskirchen GmbH, Wels
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Landeskrankenhaus Salzburg - Universitätsklinikum der PMU, Salzburg
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Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne, Yvoir
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Stichting Catharina Ziekenhuis, Eindhoven
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Tirol Kliniken - Universitätsklinik Innsbruck, Innsbruck
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Maastricht University Medical Center, Maastricht
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Landeskrankenhaus Feldkirch, Feldkirch
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AZ Sint-Jan Brugge-Campus Sint-Jan, Bruges
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LKH Universitätsklinikum Graz, Graz
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Aarhus University Hospital I, Aarhus
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Klinikum Klagenfurt am Wörthersee, Klagenfurt
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OLV Ziekenhuis Campus Aalst, Aalst
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Universitair Medisch Center Groningen, Groningen
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Charité - Universitätsmedizin Berlin (CCM), Berlin
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Sana Klinikum Lichtenberg, Berlin
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Charité - Universitätsmedizin Berlin (CBF), Berlin
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BG Klinikum Unfallkrankenhaus Berlin, Berlin
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Charité - Universitätsmedizin Berlin (CVK), Berlin
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Vivantes Humboldt Klinikum, Berlin
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Universitätsmedizin Greifswald, Greifswald
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Asklepios Kliniken Hamburg, Hamburg
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Asklepios Klinikum Harburg, Hamburg
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Albertinen Herz- und Gefäßzentrum, Hamburg
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Universitätsklinikum Schleswig-Holstein, Lübeck
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Segeberger Kliniken Gmbh, Bad Segeberg
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FEK - Friedrich-Ebert-Krankenhaus Neumünster, Neumünster
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La Paz University Hospital, Madrid
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Hospital Universitario Virgen de la Arrixaca, Murcia
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University Hospital Rangueil Toulouse, Toulouse
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Clinique Pasteur, Toulouse
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Johannes Wesling Klinikum, Minden
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Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen
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Klinikum Gütersloh, Gütersloh
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Klinikum Bielefeld, Bielefeld
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Chu de Rennes, Rennes
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Georg-August-Universität Göttingen - Universitätsmedizin Göttingen, Göttingen
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University Hospital Grenoble-Alpes, Grenoble
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Helios Universitätsklinikum Wuppertal, Wuppertal
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Elisabeth-Krankenhaus Essen, Essen
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St. Marien-Krankenhaus - Klinikum Westmünsterland, Ahaus
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Kerckhoff-Klinik Bad Nauheim, Bad Nauheim
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Asklepios Kliniken Langen, Langen
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Westpfalz-Klinikum GmbH, Kaiserslautern
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Européen Georges Pompidou Hospital Paris, Paris
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Städtisches Klinikum Karlsruhe, Karlsruhe
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CHU Amiens Picardie, Amiens
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Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum), München
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Klinik Rothenburg ANregiomed, Rothenburg upon Tauber
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Centre Cardiologique du Nord, Saint-Denis
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CHU Henri Mondor, Créteil
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REGIOMED Klinikum Coburg, Coburg
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Rambam Health Care Campus, Haifa
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Fakultní Nemocnice Olomouc, Olomouc
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Všeobecná Fakultní Nemocnice v Praze, Prague
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Institut Klinické a Experimentální Medicíny, Prague
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Masaryk Hospital, Ústí nad Labem
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Helios Klinikum Aue, Aue
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Carl-Thiem-Klinikum, Cottbus
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Städtisches Klinikum Dresden, Dresden
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Technische Universität Dresden - Herzzentrum Dresden, Dresden
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Universitätsklinikum Jena, Jena
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Universitätsklinikum Leipzig, Leipzig
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Klinikum St. Georg, Leipzig
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Herzzentrum Leipzig, Leipzig
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Medisch Spectrum Twente, Enschede
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Kliniczny Szpital Wojewódzki Nr 2 im.Św.Jadwigi Królowej w Rzeszowie, Rzeszów
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Wojskowy Instytut Medyczny, Warsaw
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Śląskie Centrum Chorób Serca w Zabrzu, Zabrze
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Hospital General Universitario de Alicante, Alicante
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The Leeds Teaching Hospitals NHS Trust - St James's University Hospital, Leeds
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Queen Elizabeth The Queen Mother Hospital Margate, Margate
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George Eliot Hospital, Nuneaton
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University Hospital of North Tees, Stockton-on-Tees
Charite University, Berlin, Germany
OTHER