Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
NCT ID: NCT05665608
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3595 participants
INTERVENTIONAL
2023-11-16
2027-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Naïve to implantation of any pacemaker or defibrillator
3. 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.
4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
5. On OMT for at least 3 months prior to enrolment.
6. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging \[MRI\] at least 3 months after MI).
7. Signed informed consent.
Inclusion criterion I3 defines myocardial infarction according to the 2018 ESC/ACC/AHA/WHF Fourth Universal Definition of myocardial infarction
Exclusion Criteria
2. Ventricular tachycardia induced in an electrophysiologic study.
3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
5. Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
8. On the waiting list for heart transplantation.
Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD.
9. Any known disease that limits life expectancy to less than 1 year.
10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.
11. Previous participation in PROFID EHRA.
Parallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Daniela Fischer
Project Manager
Principal Investigators
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Gerhard Hindricks, Prof
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine
Nikolaos Dagres, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine
Locations
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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
CHU Henri Mondor
Créteil, , France
University Hospital Grenoble-Alpes
Grenoble, , France
Européen Georges Pompidou Hospital Paris
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
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
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
La Paz University Hospital
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
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
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Countries
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Central Contacts
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References
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Dagres N, Gale CP, Nadarajah R, Boveda S, Merino JL, Nielsen JC, Kirchhof P, Kutyifa V, Taborsky M, Thiele H, Tijssen JGP, Verma A, De Potter T, Braunschweig F, Merkely B, Sommer P, Vernooy K, Suleiman M, Purerfellner H, Hindricks G; PROFID EHRA trial investigators. PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial. Am Heart J. 2026 Jan;291:37-43. doi: 10.1016/j.ahj.2025.07.071. Epub 2025 Aug 6.
Other Identifiers
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LHS-2019-0209
Identifier Type: -
Identifier Source: org_study_id
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