Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• Naïve to implantation of any pacemaker or defibrillator

• Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment.

• Symptomatic heart failure with New York Heart Association (NYHA) class II or III.

• On OMT for at least 3 months prior to enrolment.

• LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging \[MRI\] at least 3 months after MI).

• Signed informed consent.

⁃ Inclusion criterion I3 defines myocardial infarction according to the 2018 ESC/ACC/AHA/WHF Fourth Universal Definition of myocardial infarction

Locations
Other Locations
Austria
Landeskrankenhaus Feldkirch
RECRUITING
Feldkirch
LKH Universitätsklinikum Graz
RECRUITING
Graz
Tirol Kliniken - Universitätsklinik Innsbruck
RECRUITING
Innsbruck
Klinikum Klagenfurt am Wörthersee
RECRUITING
Klagenfurt
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Landeskrankenhaus Salzburg - Universitätsklinikum der PMU
RECRUITING
Salzburg
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Klinikum Wels-Grieskirchen GmbH
RECRUITING
Wels
Universitätsklinikum Wiener Neustadt
RECRUITING
Wiener Neustadt
Belgium
OLV Ziekenhuis Campus Aalst
RECRUITING
Aalst
AZ Sint-Jan Brugge-Campus Sint-Jan
RECRUITING
Bruges
Centre hospitaliser régional (CHR) de la Citadelle
RECRUITING
Liège
Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne
RECRUITING
Yvoir
Denmark
Aarhus University Hospital I
RECRUITING
Aarhus
France
CHU Amiens Picardie
RECRUITING
Amiens
CHU Henri Mondor
RECRUITING
Créteil
University Hospital Grenoble-Alpes
RECRUITING
Grenoble
Européen Georges Pompidou Hospital Paris
RECRUITING
Paris
Chu de Rennes
RECRUITING
Rennes
Centre Cardiologique du Nord
RECRUITING
Saint-denis
Clinique Pasteur
RECRUITING
Toulouse
University Hospital Rangueil Toulouse
RECRUITING
Toulouse
Germany
St. Marien-Krankenhaus - Klinikum Westmünsterland
RECRUITING
Ahaus
Helios Klinikum Aue
RECRUITING
Aue
Kerckhoff-Klinik Bad Nauheim
RECRUITING
Bad Nauheim
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
RECRUITING
Bad Oeynhausen
Segeberger Kliniken Gmbh
RECRUITING
Bad Segeberg
BG Klinikum Unfallkrankenhaus Berlin
RECRUITING
Berlin
Charité - Universitätsmedizin Berlin (CBF)
RECRUITING
Berlin
Charité - Universitätsmedizin Berlin (CCM)
RECRUITING
Berlin
Charité - Universitätsmedizin Berlin (CVK)
RECRUITING
Berlin
Sana Klinikum Lichtenberg
RECRUITING
Berlin
Vivantes Humboldt Klinikum
RECRUITING
Berlin
Klinikum Bielefeld
RECRUITING
Bielefeld
REGIOMED Klinikum Coburg
RECRUITING
Coburg
Carl-Thiem-Klinikum
RECRUITING
Cottbus
Städtisches Klinikum Dresden
RECRUITING
Dresden
Technische Universität Dresden - Herzzentrum Dresden
RECRUITING
Dresden
Elisabeth-Krankenhaus Essen
RECRUITING
Essen
Georg-August-Universität Göttingen - Universitätsmedizin Göttingen
RECRUITING
Göttingen
Universitätsmedizin Greifswald
RECRUITING
Greifswald
Klinikum Gütersloh
RECRUITING
Gütersloh
Albertinen Herz- und Gefäßzentrum
RECRUITING
Hamburg
Asklepios Kliniken Hamburg
RECRUITING
Hamburg
Asklepios Klinikum Harburg
RECRUITING
Hamburg
Universitätsklinikum Jena
RECRUITING
Jena
Westpfalz-Klinikum GmbH
RECRUITING
Kaiserslautern
Städtisches Klinikum Karlsruhe
RECRUITING
Karlsruhe
Asklepios Kliniken Langen
RECRUITING
Langen
Herzzentrum Leipzig
RECRUITING
Leipzig
Klinikum St. Georg
RECRUITING
Leipzig
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein
RECRUITING
Lübeck
Johannes Wesling Klinikum
RECRUITING
Minden
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
RECRUITING
München
FEK - Friedrich-Ebert-Krankenhaus Neumünster
RECRUITING
Neumünster
Klinik Rothenburg ANregiomed
RECRUITING
Rothenburg Upon Tauber
Helios Universitätsklinikum Wuppertal
RECRUITING
Wuppertal
Hungary
Semmelweis University
RECRUITING
Budapest
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Stichting Catharina Ziekenhuis
RECRUITING
Eindhoven
Medisch Spectrum Twente
RECRUITING
Enschede
Universitair Medisch Center Groningen
RECRUITING
Groningen
Maastricht University Medical Center
RECRUITING
Maastricht
Poland
Kliniczny Szpital Wojewódzki Nr 2 im.Św.Jadwigi Królowej w Rzeszowie
RECRUITING
Rzeszów
Wojskowy Instytut Medyczny
RECRUITING
Warsaw
Śląskie Centrum Chorób Serca w Zabrzu
RECRUITING
Zabrze
Spain
Hospital General Universitario de Alicante
RECRUITING
Alicante
La Paz University Hospital
RECRUITING
Madrid
Hospital Universitario Virgen de la Arrixaca
RECRUITING
Murcia
United Kingdom
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
RECRUITING
Leeds
Queen Elizabeth The Queen Mother Hospital Margate
RECRUITING
Margate
George Eliot Hospital
RECRUITING
Nuneaton
University Hospital of North Tees
RECRUITING
Stockton-on-tees
Contact Information
Primary
Gerhard Hindricks, Prof
Gerhard.Hindricks@dhzc-charite.de
+49 30 450 513211
Backup
Nikolaos Dagres, MD
Nikolaos.Dagres@dhzc-charite.de
+49 30 450 665407
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 3595
Treatments
Active_comparator: Optimal Medical Therapy with ICD device therapy
Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device
Experimental: Optimal Medical Therapy without ICD device therapy
Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device
Sponsors
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov