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Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Sponsor: Charite University, Berlin, Germany
Summary
Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3595
Start Date
2023-11-16
Completion Date
2027-11-30
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
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
Locations (86)
Landeskrankenhaus Feldkirch
Feldkirch, Austria
LKH Universitätsklinikum Graz
Graz, Austria
Tirol Kliniken - Universitätsklinik Innsbruck
Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
Landeskrankenhaus Salzburg - Universitätsklinikum der PMU
Salzburg, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
Universitätsklinikum Wiener Neustadt
Wiener Neustadt, Austria
OLV Ziekenhuis Campus Aalst
Aalst, Belgium
AZ Sint-Jan Brugge-Campus Sint-Jan
Bruges, Belgium
Centre hospitaliser régional (CHR) de la Citadelle
Liège, Belgium
Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne
Yvoir, Belgium
Fakultní Nemocnice Olomouc
Olomouc, Czechia
Všeobecná Fakultní Nemocnice v Praze
Prague, Czechia
Institut Klinické a Experimentální Medicíny
Prague, Czechia
Masaryk Hospital
Ústí nad Labem, Czechia
Aarhus University Hospital I
Aarhus, Denmark
CHU Amiens Picardie
Amiens, France
Hôpital de la Cavale Blanche-CHU BREST
Brest, France
CHU Henri Mondor
Créteil, France
University Hospital Grenoble-Alpes
Grenoble, France
Européen Georges Pompidou Hospital Paris
Paris, France
Hôpital Bichat Claude Bernard
Paris, France
Chu de Rennes
Rennes, France
Centre Cardiologique du Nord
Saint-Denis, France
University Hospital Rangueil Toulouse
Toulouse, France
Clinique Pasteur
Toulouse, France
St. Marien-Krankenhaus - Klinikum Westmünsterland
Ahaus, Germany
Helios Klinikum Aue
Aue, Germany
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Segeberger Kliniken Gmbh
Bad Segeberg, Germany
Charité - Universitätsmedizin Berlin (CCM)
Berlin, Germany
Sana Klinikum Lichtenberg
Berlin, Germany
Charité - Universitätsmedizin Berlin (CBF)
Berlin, Germany
BG Klinikum Unfallkrankenhaus Berlin
Berlin, Germany
Charité - Universitätsmedizin Berlin (CVK)
Berlin, Germany
Vivantes Humboldt Klinikum
Berlin, Germany
Klinikum Bielefeld
Bielefeld, Germany
REGIOMED Klinikum Coburg
Coburg, Germany
Carl-Thiem-Klinikum
Cottbus, Germany
Städtisches Klinikum Dresden
Dresden, Germany
Technische Universität Dresden - Herzzentrum Dresden
Dresden, Germany
Elisabeth-Krankenhaus Essen
Essen, Germany
Georg-August-Universität Göttingen - Universitätsmedizin Göttingen
Göttingen, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Klinikum Gütersloh
Gütersloh, Germany
Asklepios Kliniken Hamburg
Hamburg, Germany
Asklepios Klinikum Harburg
Hamburg, Germany
Albertinen Herz- und Gefäßzentrum
Hamburg, Germany
Universitätsklinikum Jena
Jena, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
B.Braun Ambulantes Herzzentrum Kassel
Kassel, Germany
Asklepios Kliniken Langen
Langen, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum St. Georg
Leipzig, Germany
Herzzentrum Leipzig
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Johannes Wesling Klinikum
Minden, Germany
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
München, Germany
FEK - Friedrich-Ebert-Krankenhaus Neumünster
Neumünster, Germany
Klinik Rothenburg ANregiomed
Rothenburg upon Tauber, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany
Semmelweis University
Budapest, Hungary
Rambam Health Care Campus
Haifa, Israel
Le Centre Hospitalier Universitaire de Martinique
Fort-de-France Cedex, Martinique
Amsterdam UMC
Amsterdam, Netherlands
Stichting Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Universitair Medisch Center Groningen
Groningen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Kliniczny Szpital Wojewódzki Nr 2 im.Św.Jadwigi Królowej w Rzeszowie
Rzeszów, Poland
Wojskowy Instytut Medyczny
Warsaw, Poland
Śląskie Centrum Chorób Serca w Zabrzu
Zabrze, Poland
Hospital General Universitario de Alicante
Alicante, Spain
Instituto de Investigación Hospital 12 de Octubre
Madrid, Spain
La Paz University Hospital
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Calderdale Royal Hospital
Halifax, United Kingdom
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds, United Kingdom
Queen Elizabeth The Queen Mother Hospital Margate
Margate, United Kingdom
George Eliot Hospital
Nuneaton, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, United Kingdom