Preventing sudden cardiac death after heart attacks with defibrillator implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of implantable cardioverter-defibrillators (ICDs) in preventing sudden cardiac death (SCD) in patients who have survived a myocardial infarction (MI) and have severely reduced left ventricular ejection fraction (LVEF). Participants will receive either an ICD or optimal medical therapy (OMT) to assess which approach leads to better survival outcomes. The study builds on previous landmark trials that established the benefits of ICDs in similar patient populations. The goal is to provide evidence for routine ICD implantation as a preventive measure for SCD in high-risk MI survivors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Landeskrankenhaus Feldkirch
  Feldkirch, Austria Recruiting
• LKH Universitätsklinikum Graz
  Graz, Austria Recruiting
• Tirol Kliniken - Universitätsklinik Innsbruck
  Innsbruck, Austria Recruiting
• Klinikum Klagenfurt am Wörthersee
  Klagenfurt, Austria Recruiting
• Ordensklinikum Linz GmbH Elisabethinen
  Linz, Austria Recruiting
• Landeskrankenhaus Salzburg - Universitätsklinikum der PMU
  Salzburg, Austria Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Gerhard Hindricks, Prof — Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine
• Study coordinator: Gerhard Hindricks, Prof
• Email: Gerhard.Hindricks@dhzc-charite.de
• Phone: +49 30 450 513211

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surgery to treat myocardial bridge in coronary arteries

  This study tests if a special heart surgery can help people with symptoms from a condition called myocardial bridge feel better and improve their quality of life.

  Recruiting Xi'an International Medical Center Hospital · Xi'an, Shaanxi · NCT06857838

• Heart@Home: Safe, at-home care for people with acute heart problems compared with hospital care

  This trial tests whether hospital-level care at home can safely and effectively treat adults with acute heart conditions who would normally be in the hospital.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07913152

• Digital cardiac rehab to help heart attack patients improve function

  A digital health–supported cardiac rehabilitation program is being tested to see if it helps people after a heart attack improve fitness and stay engaged with rehab, compared with standard outpatient rehab.

  Recruiting Cairo University · Minya, Minya Province · NCT07867197

• NMR-based Risk Test and Digital Health Support for midlife adults in Eloisa

  This study tests whether an NMR metabolomics risk test can guide tailored digital health programs for midlife adults at risk of diabetes, heart disease, stroke, kidney disease, or fatty liver.

  Recruiting University of Eastern Finland · Savonlinna · NCT07820800

• See if stopping long-term aspirin is as good as continuing it in older adults with stable ischemic heart disease

  In adults 65 and older with stable ischemic heart disease, this trial tests whether stopping daily low-dose aspirin is not worse than continuing it.

  Recruiting at 2 sites Phase 4 Odense University Hospital · Copenhagen and 1 other locations · NCT07795398

• Innate Immune Cells and Early Fibrotic Repair After a Heart Attack

  This study tests whether specific neutrophil and monocyte patterns are linked to early scar formation after a heart attack in STEMI patients.

  Recruiting Shanghai 10th People's Hospital · Shanghai · NCT07764588

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.