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AzTrials

Sudden Cardiac DeathPROFID EHRANCT05665608

Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

A study testing Implantable cardioverter-defibrillator (ICD) and Optimal Medical Therapy (OMT) in people with Sudden Cardiac Death and Myocardial Infarction, run by Charite University, Berlin, Germany at 86 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sudden Cardiac Death, Myocardial Infarction
What is being tested?
Implantable cardioverter-defibrillator (ICD) and Optimal Medical Therapy (OMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,595 participants
Where
86 sitesin 13 countries
Study dates
16 Nov 2023to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
  • Ventricular tachycardia induced in an electrophysiologic study.
  • Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
  • Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
  • Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
  • Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
Show all 13Show fewer
  • Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
  • 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.
  • Any known disease that limits life expectancy to less than 1 year.
  • Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.
  • 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.

Trial locations and contacts

86 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Gerhard Hindricks, Prof contact

+49 30 450 513211

Gerhard.Hindricks@dhzc-charite.de

Nikolaos Dagres, MD contact

+49 30 450 665407

Nikolaos.Dagres@dhzc-charite.de

86 sites in 13 countries

Germany37 sites, 35 recruiting

  • St. Marien-Krankenhaus - Klinikum Westmünsterland

    Ahaus, 48683

    Withdrawn

  • Helios Klinikum Aue

    Aue, 08280

    Recruiting

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim, 61231

    Recruiting

  • Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum

    Bad Oeynhausen, 32545

    Recruiting

  • Segeberger Kliniken Gmbh

    Bad Segeberg, 23795

    Recruiting

  • Charité - Universitätsmedizin Berlin (CCM)

    Berlin, 10117

    Recruiting

  • Sana Klinikum Lichtenberg

    Berlin, 10365

    Recruiting

  • Charité - Universitätsmedizin Berlin (CBF)

    Berlin, 12203

    Recruiting

  • BG Klinikum Unfallkrankenhaus Berlin

    Berlin, 12683

    Recruiting

  • Charité - Universitätsmedizin Berlin (CVK)

    Berlin, 13353

    Recruiting

  • Vivantes Humboldt Klinikum

    Berlin, 13509

    Withdrawn

  • Klinikum Bielefeld

    Bielefeld, 33604

    Recruiting

  • REGIOMED Klinikum Coburg

    Coburg, 96450

    Recruiting

  • Carl-Thiem-Klinikum

    Cottbus, 03048

    Recruiting

  • Städtisches Klinikum Dresden

    Dresden, 01067

    Recruiting

  • Technische Universität Dresden - Herzzentrum Dresden

    Dresden, 01307

    Recruiting

  • Elisabeth-Krankenhaus Essen

    Essen, 45138

    Recruiting

  • Georg-August-Universität Göttingen - Universitätsmedizin Göttingen

    Göttingen, 37075

    Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475

    Recruiting

  • Klinikum Gütersloh

    Gütersloh, 33332

    Recruiting

  • Asklepios Kliniken Hamburg

    Hamburg, 20099

    Recruiting

  • Asklepios Klinikum Harburg

    Hamburg, 21075

    Recruiting

  • Albertinen Herz- und Gefäßzentrum

    Hamburg, 22457

    Recruiting

  • Universitätsklinikum Jena

    Jena, 07747

    Recruiting

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

    Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

    Recruiting

  • B.Braun Ambulantes Herzzentrum Kassel

    Kassel, 34121

    Recruiting

  • Asklepios Kliniken Langen

    Langen, 63225

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Klinikum St. Georg

    Leipzig, 04129

    Recruiting

  • Herzzentrum Leipzig

    Leipzig, 04289

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

    Recruiting

  • Johannes Wesling Klinikum

    Minden, 32429

    Recruiting

  • Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)

    München, 81377

    Recruiting

  • FEK - Friedrich-Ebert-Krankenhaus Neumünster

    Neumünster, 24534

    Recruiting

  • Klinik Rothenburg ANregiomed

    Rothenburg upon Tauber, 91541

    Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42117

    Recruiting

Other trials in Germany

France10 sites, 10 recruiting

  • CHU Amiens Picardie

    Amiens, 80054

    Recruiting

  • Hôpital de la Cavale Blanche-CHU BREST

    Brest, 29609

    Recruiting

  • CHU Henri Mondor

    Créteil, 94010

    Recruiting

  • University Hospital Grenoble-Alpes

    Grenoble, 38700

    Recruiting

  • Européen Georges Pompidou Hospital Paris

    Paris, 75015

    Recruiting

  • Hôpital Bichat Claude Bernard

    Paris, 75018

    Recruiting

  • Chu de Rennes

    Rennes, 35000

    Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

    Recruiting

  • University Hospital Rangueil Toulouse

    Toulouse, 31059

    Recruiting

  • Clinique Pasteur

    Toulouse, 31076

    Recruiting

Other trials in France

Austria9 sites, 9 recruiting

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800

    Recruiting

  • LKH Universitätsklinikum Graz

    Graz, 8036

    Recruiting

  • Tirol Kliniken - Universitätsklinik Innsbruck

    Innsbruck, 6020

    Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

    Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

    Recruiting

  • Landeskrankenhaus Salzburg - Universitätsklinikum der PMU

    Salzburg, 5020

    Recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

    Recruiting

  • Universitätsklinikum Wiener Neustadt

    Wiener Neustadt, 2700

    Recruiting

Other trials in Austria

United Kingdom6 sites, 6 recruiting

  • Calderdale Royal Hospital

    Halifax, HX3 0PW

    Recruiting

  • The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

    Leeds, LS9 7TF

    Recruiting

  • Queen Elizabeth The Queen Mother Hospital Margate

    Margate, CT9 4AN

    Recruiting

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

    Recruiting

  • Salisbury District Hospital

    Salisbury, SP2 8BJ

    Recruiting

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE

    Recruiting

Other trials in United Kingdom

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC

    Amsterdam, 1105

    Recruiting

  • Stichting Catharina Ziekenhuis

    Eindhoven, 5623

    Recruiting

  • Medisch Spectrum Twente

    Enschede, 7512 KZ

    Recruiting

  • Universitair Medisch Center Groningen

    Groningen, 9700

    Recruiting

  • Maastricht University Medical Center

    Maastricht, 6229

    Recruiting

Other trials in Netherlands

Belgium4 sites, 4 recruiting

  • OLV Ziekenhuis Campus Aalst

    Aalst, 9300

    Recruiting

  • AZ Sint-Jan Brugge-Campus Sint-Jan

    Bruges, 8000

    Recruiting

  • Centre hospitaliser régional (CHR) de la Citadelle

    Liège, 4000

    Recruiting

  • Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne

    Yvoir, 5530

    Recruiting

Other trials in Belgium

Czechia4 sites, 3 recruiting

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00

    Terminated

  • Všeobecná Fakultní Nemocnice v Praze

    Prague, 128 08

    Recruiting

  • Institut Klinické a Experimentální Medicíny

    Prague, 140 21

    Recruiting

  • Masaryk Hospital

    Ústí nad Labem, 400 11

    Recruiting

Other trials in Czechia

Spain4 sites, 4 recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010

    Recruiting

  • Instituto de Investigación Hospital 12 de Octubre

    Madrid, 28041

    Recruiting

  • La Paz University Hospital

    Madrid, 28046

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

    Recruiting

Other trials in Spain

Poland3 sites, 3 recruiting

  • Kliniczny Szpital Wojewódzki Nr 2 im.Św.Jadwigi Królowej w Rzeszowie

    Rzeszów, 35-301

    Recruiting

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

    Recruiting

  • Śląskie Centrum Chorób Serca w Zabrzu

    Zabrze, 41-800

    Recruiting

Other trials in Poland

Denmark1 site, 1 recruiting

  • Aarhus University Hospital I

    Aarhus, 8200

    Recruiting

Other trials in Denmark

Hungary1 site, 1 recruiting

  • Semmelweis University

    Budapest, 1085

    Recruiting

Other trials in Hungary

Israel1 site, 1 recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Recruiting

Other trials in Israel

Martinique1 site, 1 recruiting

  • Le Centre Hospitalier Universitaire de Martinique

    Fort-de-France Cedex, 97261

    Recruiting

Other trials in Martinique

About this study

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.

Being tested
Implantable cardioverter-defibrillator (ICD), Optimal Medical Therapy (OMT)
Keywords
Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Myocardial Infarction
Medical subject headings
Death, Sudden, Cardiac, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable cardioverter-defibrillator (ICD)Device

    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)Drug

    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
Study groups in NCT05665608
Study groupRoleWhat they receive
Optimal Medical Therapy with ICD device therapyActive comparatorPatients 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
Receives: Device: Implantable cardioverter-defibrillator (ICD); Drug: Optimal Medical Therapy (OMT)
Optimal Medical Therapy without ICD device therapyExperimentalPatients 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
Receives: Drug: Optimal Medical Therapy (OMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from randomisation to the occurrence of all-cause death.

    Randomization to end of study

    Measured: event-driven, expected about 15 months after last patient in

Secondary outcomes (5)

  1. Time from randomisation to death from cardiovascular causes

    Time from randomisation to death from cardiovascular causes

    Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in

  2. Time from randomisation to sudden cardiac death

    Time from randomisation to sudden cardiac death

    Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in

  3. Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation

    Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation

    Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in

  4. Average length of stay in hospital during the study period

    Average length of stay in hospital during the study period

    Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in

  5. Quality of life (EQ-5D-5L) trajectories over time

    Quality of life (EQ-5D-5L) trajectories over time

    Measured: At baseline and 12-month intervals thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start16 Nov 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
An investigator-driven, prospective, parallel-group, randomised, open, blinded outcome assessment (PROBE), multi-centre, non-inferiority trial without investigational medical products (Proof of Strategy Trial)
Masking
None (open label)
Enrolment
3,595 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665608
Sponsor's protocol ID
LHS-2019-0209
Acronym
PROFID EHRA
Status last verified
Mar 2026
First submitted
19 Dec 2022
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Qian Y, Roque CR, Woods B, Iglesias Urrutia CP, Gc VS, Gur Arie M, Fischer D, Dagres N, Hindricks G, Manca A. Economic evaluation protocol for the PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantation: the PROFID EHRA trial. BMJ Open. 2026 Jan 8;16(1):e097495. doi: 10.1136/bmjopen-2024-097495.

    PubMed 41506764

  • 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.

    PubMed 40774643

Questions about this trial

What is this clinical trial studying?

A study testing Implantable cardioverter-defibrillator (ICD) and Optimal Medical Therapy (OMT) in people with Sudden Cardiac Death and Myocardial Infarction, run by Charite University, Berlin, Germany at 86 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Germany, France, Austria, United Kingdom, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gerhard Hindricks, Prof (+49 30 450 513211, Gerhard.Hindricks@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomisation to the occurrence of all-cause death. (time frame: event-driven, expected about 15 months after last patient in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665608, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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