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Heart attack survivors may skip risky defibrillator implant, landmark trial asks

NCT ID NCT05665608

Prevention Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two approaches for heart attack survivors with weak hearts: taking modern medications alone versus getting a defibrillator implant plus medications. The goal is to see if medication alone is as good at preventing sudden cardiac death. About 3,600 participants will be followed for years to measure survival rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,595 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years. 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: 1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia. 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.

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac heart failure myocardial infarction sudden cardiac arrest sudden arrhythmia death syndrome prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocardial infarction Sudden cardiac death

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Campus Sint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • Aarhus University Hospital I

    RECRUITING

    Aarhus, 8200, Denmark

  • Albertinen Herz- und Gefäßzentrum

    RECRUITING

    Hamburg, 22457, Germany

  • Amsterdam UMC

    RECRUITING

    Amsterdam, 1105, Netherlands

  • Asklepios Kliniken Hamburg

    RECRUITING

    Hamburg, 20099, Germany

  • Asklepios Kliniken Langen

    RECRUITING

    Langen, 63225, Germany

  • Asklepios Klinikum Harburg

    RECRUITING

    Hamburg, 21075, Germany

  • B.Braun Ambulantes Herzzentrum Kassel

    RECRUITING

    Kassel, 34121, Germany

  • BG Klinikum Unfallkrankenhaus Berlin

    RECRUITING

    Berlin, 12683, Germany

  • CHU Amiens Picardie

    RECRUITING

    Amiens, 80054, France

  • CHU Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Calderdale Royal Hospital

    RECRUITING

    Halifax, HX3 0PW, United Kingdom

  • Carl-Thiem-Klinikum

    RECRUITING

    Cottbus, 03048, Germany

  • Centre Cardiologique du Nord

    RECRUITING

    Saint-Denis, 93200, France

  • Centre Hospitalier Universitaire CHU UCL Namur - Site Godinne

    RECRUITING

    Yvoir, 5530, Belgium

  • Centre hospitaliser régional (CHR) de la Citadelle

    RECRUITING

    Liège, 4000, Belgium

  • Charité - Universitätsmedizin Berlin (CBF)

    RECRUITING

    Berlin, 12203, Germany

  • Charité - Universitätsmedizin Berlin (CCM)

    RECRUITING

    Berlin, 10117, Germany

  • Charité - Universitätsmedizin Berlin (CVK)

    RECRUITING

    Berlin, 13353, Germany

  • Chu de Rennes

    RECRUITING

    Rennes, 35000, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Elisabeth-Krankenhaus Essen

    RECRUITING

    Essen, 45138, Germany

  • Européen Georges Pompidou Hospital Paris

    RECRUITING

    Paris, 75015, France

  • FEK - Friedrich-Ebert-Krankenhaus Neumünster

    RECRUITING

    Neumünster, 24534, Germany

  • Fakultní Nemocnice Olomouc

    TERMINATED

    Olomouc, 779 00, Czechia

  • Georg-August-Universität Göttingen - Universitätsmedizin Göttingen

    RECRUITING

    Göttingen, 37075, Germany

  • George Eliot Hospital

    RECRUITING

    Nuneaton, CV10 7DJ, United Kingdom

  • Helios Klinikum Aue

    RECRUITING

    Aue, 08280, Germany

  • Helios Universitätsklinikum Wuppertal

    RECRUITING

    Wuppertal, 42117, Germany

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

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Herzzentrum Leipzig

    RECRUITING

    Leipzig, 04289, Germany

  • Hospital General Universitario de Alicante

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hôpital Bichat Claude Bernard

    RECRUITING

    Paris, 75018, France

  • Hôpital de la Cavale Blanche-CHU BREST

    RECRUITING

    Brest, 29609, France

  • Institut Klinické a Experimentální Medicíny

    RECRUITING

    Prague, 140 21, Czechia

  • Instituto de Investigación Hospital 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Johannes Wesling Klinikum

    RECRUITING

    Minden, 32429, Germany

  • Kerckhoff-Klinik Bad Nauheim

    RECRUITING

    Bad Nauheim, 61231, Germany

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

    RECRUITING

    Rzeszów, 35-301, Poland

  • Klinik Rothenburg ANregiomed

    RECRUITING

    Rothenburg upon Tauber, 91541, Germany

  • Klinikum Bielefeld

    RECRUITING

    Bielefeld, 33604, Germany

  • Klinikum Gütersloh

    RECRUITING

    Gütersloh, 33332, Germany

  • Klinikum Klagenfurt am Wörthersee

    RECRUITING

    Klagenfurt, 9020, Austria

  • Klinikum St. Georg

    RECRUITING

    Leipzig, 04129, Germany

  • Klinikum Wels-Grieskirchen GmbH

    RECRUITING

    Wels, 4600, Austria

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

    RECRUITING

    München, 81377, Germany

  • LKH Universitätsklinikum Graz

    RECRUITING

    Graz, 8036, Austria

  • La Paz University Hospital

    RECRUITING

    Madrid, 28046, Spain

  • Landeskrankenhaus Feldkirch

    RECRUITING

    Feldkirch, 6800, Austria

  • Landeskrankenhaus Salzburg - Universitätsklinikum der PMU

    RECRUITING

    Salzburg, 5020, Austria

  • Le Centre Hospitalier Universitaire de Martinique

    RECRUITING

    Fort-de-France Cedex, 97261, Martinique

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, 6229, Netherlands

  • Masaryk Hospital

    RECRUITING

    Ústí nad Labem, 400 11, Czechia

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, 7512 KZ, Netherlands

  • OLV Ziekenhuis Campus Aalst

    RECRUITING

    Aalst, 9300, Belgium

  • Ordensklinikum Linz GmbH Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Queen Elizabeth The Queen Mother Hospital Margate

    RECRUITING

    Margate, CT9 4AN, United Kingdom

  • REGIOMED Klinikum Coburg

    RECRUITING

    Coburg, 96450, Germany

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Salisbury District Hospital

    RECRUITING

    Salisbury, SP2 8BJ, United Kingdom

  • Sana Klinikum Lichtenberg

    RECRUITING

    Berlin, 10365, Germany

  • Segeberger Kliniken Gmbh

    RECRUITING

    Bad Segeberg, 23795, Germany

  • Semmelweis University

    RECRUITING

    Budapest, 1085, Hungary

  • St. Marien-Krankenhaus - Klinikum Westmünsterland

    WITHDRAWN

    Ahaus, 48683, Germany

  • Stichting Catharina Ziekenhuis

    RECRUITING

    Eindhoven, 5623, Netherlands

  • Städtisches Klinikum Dresden

    RECRUITING

    Dresden, 01067, Germany

  • Städtisches Klinikum Karlsruhe

    RECRUITING

    Karlsruhe, 76133, Germany

  • Technische Universität Dresden - Herzzentrum Dresden

    RECRUITING

    Dresden, 01307, Germany

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

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Tirol Kliniken - Universitätsklinik Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Universitair Medisch Center Groningen

    RECRUITING

    Groningen, 9700, Netherlands

  • University Hospital Grenoble-Alpes

    RECRUITING

    Grenoble, 38700, France

  • University Hospital Rangueil Toulouse

    RECRUITING

    Toulouse, 31059, France

  • University Hospital of North Tees

    RECRUITING

    Stockton-on-Tees, TS19 8PE, United Kingdom

  • Universitätsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Lübeck, 23538, Germany

  • Universitätsklinikum St. Pölten

    RECRUITING

    Sankt Pölten, 3100, Austria

  • Universitätsklinikum Wiener Neustadt

    RECRUITING

    Wiener Neustadt, 2700, Austria

  • Universitätsmedizin Greifswald

    RECRUITING

    Greifswald, 17475, Germany

  • Vivantes Humboldt Klinikum

    WITHDRAWN

    Berlin, 13509, Germany

  • Všeobecná Fakultní Nemocnice v Praze

    RECRUITING

    Prague, 128 08, Czechia

  • Westpfalz-Klinikum GmbH

    RECRUITING

    Kaiserslautern, 67655, Germany

  • Wojskowy Instytut Medyczny

    RECRUITING

    Warsaw, 04-141, Poland

  • Śląskie Centrum Chorób Serca w Zabrzu

    RECRUITING

    Zabrze, 41-800, Poland

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