Actively Recruiting
Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Led by Charite University, Berlin, Germany · Updated on 2026-04-01
3595
Participants Needed
86
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No previous implantation of any pacemaker or defibrillator
- Documented history of myocardial infarction (STEMI or NSTEMI) at least 3 months before enrollment
- Symptomatic heart failure with New York Heart Association (NYHA) class II or III
- On optimal medical therapy for at least 3 months before enrollment
- Left ventricular ejection fraction (LVEF) 35% or less measured at least 3 months after myocardial infarction
- Signed informed consent
You will not qualify if you...
- Indication for ICD implantation for secondary prevention of sudden cardiac death or ventricular tachycardia (class I or IIa)
- Ventricular tachycardia induced by electrophysiologic study
- Unexplained fainting (syncope) suspected to be caused by ventricular arrhythmia
- Indication for cardiac resynchronization therapy (class I or IIa)
- Likely violation of ICD device instructions for use (applicable to control group only)
- Acute coronary syndrome, coronary angioplasty, or bypass surgery within 6 weeks before enrollment
- Cardiac valve surgery or intervention within 6 weeks before enrollment
- On waiting list for heart transplantation
- Any disease limiting life expectancy to less than 1 year
- Participation in another randomized clinical trial with active study treatment at enrollment
- Previous participation in this trial (PROFID EHRA)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6800
Actively Recruiting
2
LKH Universitätsklinikum Graz
Graz, Austria, 8036
Actively Recruiting
3
Tirol Kliniken - Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
4
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
Actively Recruiting
5
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria, 4020
Actively Recruiting
6
Landeskrankenhaus Salzburg - Universitätsklinikum der PMU
Salzburg, Austria, 5020
Actively Recruiting
7
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
8
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Actively Recruiting
9
Universitätsklinikum Wiener Neustadt
Wiener Neustadt, Austria, 2700
Actively Recruiting
10
OLV Ziekenhuis Campus Aalst
Aalst, Belgium, 9300
Actively Recruiting
11
AZ Sint-Jan Brugge-Campus Sint-Jan
Bruges, Belgium, 8000
Actively Recruiting
12
Centre hospitaliser régional (CHR) de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
13
Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne
Yvoir, Belgium, 5530
Actively Recruiting
14
Fakultní Nemocnice Olomouc
Olomouc, Czechia, 779 00
Terminated
15
Všeobecná Fakultní Nemocnice v Praze
Prague, Czechia, 128 08
Actively Recruiting
16
Institut Klinické a Experimentální Medicíny
Prague, Czechia, 140 21
Actively Recruiting
17
Masaryk Hospital
Ústí nad Labem, Czechia, 400 11
Actively Recruiting
18
Aarhus University Hospital I
Aarhus, Denmark, 8200
Actively Recruiting
19
CHU Amiens Picardie
Amiens, France, 80054
Actively Recruiting
20
Hôpital de la Cavale Blanche-CHU BREST
Brest, France, 29609
Actively Recruiting
21
CHU Henri Mondor
Créteil, France, 94010
Actively Recruiting
22
University Hospital Grenoble-Alpes
Grenoble, France, 38700
Actively Recruiting
23
Européen Georges Pompidou Hospital Paris
Paris, France, 75015
Actively Recruiting
24
Hôpital Bichat Claude Bernard
Paris, France, 75018
Actively Recruiting
25
Chu de Rennes
Rennes, France, 35000
Actively Recruiting
26
Centre Cardiologique du Nord
Saint-Denis, France, 93200
Actively Recruiting
27
University Hospital Rangueil Toulouse
Toulouse, France, 31059
Actively Recruiting
28
Clinique Pasteur
Toulouse, France, 31076
Actively Recruiting
29
St. Marien-Krankenhaus - Klinikum Westmünsterland
Ahaus, Germany, 48683
Withdrawn
30
Helios Klinikum Aue
Aue, Germany, 08280
Actively Recruiting
31
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim, Germany, 61231
Actively Recruiting
32
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, Germany, 32545
Actively Recruiting
33
Segeberger Kliniken Gmbh
Bad Segeberg, Germany, 23795
Actively Recruiting
34
Charité - Universitätsmedizin Berlin (CCM)
Berlin, Germany, 10117
Actively Recruiting
35
Sana Klinikum Lichtenberg
Berlin, Germany, 10365
Actively Recruiting
36
Charité - Universitätsmedizin Berlin (CBF)
Berlin, Germany, 12203
Actively Recruiting
37
BG Klinikum Unfallkrankenhaus Berlin
Berlin, Germany, 12683
Actively Recruiting
38
Charité - Universitätsmedizin Berlin (CVK)
Berlin, Germany, 13353
Actively Recruiting
39
Vivantes Humboldt Klinikum
Berlin, Germany, 13509
Withdrawn
40
Klinikum Bielefeld
Bielefeld, Germany, 33604
Actively Recruiting
41
REGIOMED Klinikum Coburg
Coburg, Germany, 96450
Actively Recruiting
42
Carl-Thiem-Klinikum
Cottbus, Germany, 03048
Actively Recruiting
43
Städtisches Klinikum Dresden
Dresden, Germany, 01067
Actively Recruiting
44
Technische Universität Dresden - Herzzentrum Dresden
Dresden, Germany, 01307
Actively Recruiting
45
Elisabeth-Krankenhaus Essen
Essen, Germany, 45138
Actively Recruiting
46
Georg-August-Universität Göttingen - Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Actively Recruiting
47
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Actively Recruiting
48
Klinikum Gütersloh
Gütersloh, Germany, 33332
Actively Recruiting
49
Asklepios Kliniken Hamburg
Hamburg, Germany, 20099
Actively Recruiting
50
Asklepios Klinikum Harburg
Hamburg, Germany, 21075
Actively Recruiting
51
Albertinen Herz- und Gefäßzentrum
Hamburg, Germany, 22457
Actively Recruiting
52
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
53
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany, 67655
Actively Recruiting
54
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Actively Recruiting
55
B.Braun Ambulantes Herzzentrum Kassel
Kassel, Germany, 34121
Actively Recruiting
56
Asklepios Kliniken Langen
Langen, Germany, 63225
Actively Recruiting
57
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
58
Klinikum St. Georg
Leipzig, Germany, 04129
Actively Recruiting
59
Herzzentrum Leipzig
Leipzig, Germany, 04289
Actively Recruiting
60
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
61
Johannes Wesling Klinikum
Minden, Germany, 32429
Actively Recruiting
62
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
München, Germany, 81377
Actively Recruiting
63
FEK - Friedrich-Ebert-Krankenhaus Neumünster
Neumünster, Germany, 24534
Actively Recruiting
64
Klinik Rothenburg ANregiomed
Rothenburg upon Tauber, Germany, 91541
Actively Recruiting
65
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42117
Actively Recruiting
66
Semmelweis University
Budapest, Hungary, 1085
Actively Recruiting
67
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
68
Le Centre Hospitalier Universitaire de Martinique
Fort-de-France Cedex, Martinique, 97261
Actively Recruiting
69
Amsterdam UMC
Amsterdam, Netherlands, 1105
Actively Recruiting
70
Stichting Catharina Ziekenhuis
Eindhoven, Netherlands, 5623
Actively Recruiting
71
Medisch Spectrum Twente
Enschede, Netherlands, 7512 KZ
Actively Recruiting
72
Universitair Medisch Center Groningen
Groningen, Netherlands, 9700
Actively Recruiting
73
Maastricht University Medical Center
Maastricht, Netherlands, 6229
Actively Recruiting
74
Kliniczny Szpital Wojewódzki Nr 2 im.Św.Jadwigi Królowej w Rzeszowie
Rzeszów, Poland, 35-301
Actively Recruiting
75
Wojskowy Instytut Medyczny
Warsaw, Poland, 04-141
Actively Recruiting
76
Śląskie Centrum Chorób Serca w Zabrzu
Zabrze, Poland, 41-800
Actively Recruiting
77
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Actively Recruiting
78
Instituto de Investigación Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
79
La Paz University Hospital
Madrid, Spain, 28046
Actively Recruiting
80
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
81
Calderdale Royal Hospital
Halifax, United Kingdom, HX3 0PW
Actively Recruiting
82
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
83
Queen Elizabeth The Queen Mother Hospital Margate
Margate, United Kingdom, CT9 4AN
Actively Recruiting
84
George Eliot Hospital
Nuneaton, United Kingdom, CV10 7DJ
Actively Recruiting
85
Salisbury District Hospital
Salisbury, United Kingdom, SP2 8BJ
Actively Recruiting
86
University Hospital of North Tees
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
Research Team
G
Gerhard Hindricks, Prof
CONTACT
N
Nikolaos Dagres, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here