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Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

RecruitingNAAges 18 Years - anyAllCharite University, Berlin, Germany
NCT05665608 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Implantable cardioverter-defibrillator (ICD)
  • Optimal Medical Therapy (OMT)
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Where

86 sites
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

…and 78 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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