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Preventing sudden cardiac death after heart attacks with defibrillator implantation

Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

Not applicable Interventional Charite University, Berlin, Germany · NCT05665608

This study is testing if implantable defibrillators can help heart attack survivors with weak hearts live longer and avoid sudden cardiac death compared to just taking medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3595 (estimated)
Ages18 Years and up
SexAll
SponsorCharite University, Berlin, Germany Academic / other
Locations86 sites (Feldkirch and 85 other locations)
Trial IDNCT05665608 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have a documented history of myocardial infarction and a severely reduced left ventricular ejection fraction.

Not a fit: Patients who have a class I or IIa indication for ICD implantation for secondary prevention or those with unexplained syncope may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of sudden cardiac death in patients who have survived a heart attack.

How similar studies have performed: Previous studies, such as MADIT II and SCD-HeFT, have shown significant success with similar approaches, establishing the efficacy of ICDs in preventing SCD in high-risk patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Feldkirch and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sudden Cardiac DeathMyocardial InfarctionImplantable Cardioverter Defibrillator
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.