A Phase 4 interventional study of Implantable cardioverter defibrillator in Acute Myocardial Infarction, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Phase 4, Interventional, and Diagnostic
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.
255 studies on the registry are indexed under Ventricular Dysfunction, Left; 53 are open to participants now.
This study's planned enrollment of 900 is above the median of 99 across 150 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
fulfill requirement I and/or II :
Exclusion Criteria:
The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different.
Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Device-related complications, Hospitalizations, Quality of life
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Ventricular Dysfunction, Left→
Medtronic Cardiac Rhythm and Heart Failure