PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial

Background: Randomized clinical trials from over 20 years ago demonstrated that an implantable cardioverter defibrillator (ICD) improved survival for patients with severely reduced left ventricular ejection fraction (LVEF) after myocardial infarction (MI) compared with optimal medical therapy (OMT) alone. Since then advances in therapy have led to the reduction in the incidence of sudden cardiac death (SCD) in this population, whilst complication rates from ICD implantation are still substantial. Objectives: To determine whether OMT without ICD implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality. Design: The PROFID EHRA trial is an investigator-driven, prospective, parallel-group, randomized, open-label, blinded outcome assessment (PROBE), multi-center, noninferiority trial without dedicated investigational medical device (Proof of Strategy Trial) with 2 groups with 1:1 randomization. PROFID-EHRA will recruit approximately 3,595 patients with documented history of MI at least 3 months prior, LVEF ≤35%, on OMT for at least 3 months, and with New York Heart Association class II or III, who will be randomized to OMT or OMT plus ICD, to collect 374 first primary outcome events within a median observation period of around 28 months from about 180 clinical sites in an estimated 13 countries. The primary outcome is time from randomization to the occurrence of all-cause death. Secondary outcomes include time from randomization to death from cardiovascular causes, to SCD, to first hospital readmission for cardiovascular causes after date of randomization, the average length of hospital stay during follow-up, and quality of life trajectories. Clinical Trial: Trials.gov