Arrhythmias & electrophysiology
PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial
Study context
- Population
- Patients with documented history of myocardial infarction (MI) at least 3 months prior, left ventricular ejection fraction (LVEF) ≤35%, on optimal medical therapy (OMT) for at least 3 months, and with New York Heart Association class II or IIIplanned recruitment, to collect 374 first primary outcome events within a median observation period of around 28 months
- Participants
- ≈3,595 patients
- Planned comparison
- OMT without implantable cardioverter defibrillator (ICD) implantation is not inferior to OMT with ICD implantation with respect to all-cause mortality
- Primary endpoint
- Time from randomization to the occurrence of all-cause death
Methodological detailswithout dedicated investigational medical device (Proof of Strategy Trial), 2 groups with 1:1 randomization, design and rationale (no results reported), about 180 clinical sites in an estimated 13 countries
- Without dedicated investigational medical device (Proof of Strategy Trial)
- 2 groups with 1:1 randomization
- Design and rationale (no results reported)
- About 180 clinical sites in an estimated 13 countries
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
PRevention of sudden cardiac death aFter myocardial infarction by defibrillator implantation: Design and rationale of the PROFID EHRA randomized clinical trial. Am Heart J. Published 6 August 2025. doi:10.
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