Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation (PROFID EHRA)
Sudden Cardiac Death, Myocardial Infarction
About this trial
This is an interventional prevention trial for Sudden Cardiac Death focused on measuring Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Myocardial Infarction
Eligibility Criteria
Inclusion Criteria: 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 and at least 3 months prior to enrolment. 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: 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. 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, either within the 3 months prior to enrolment or still on-going. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Optimal Medical Therapy with ICD device therapy
Optimal Medical Therapy without ICD device therapy
Patients 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
Patients 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