Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial

The primary end point is time to detection of predefined serious arrhythmic events during follow-up, including atrial fibrillation ≥6 minutes, nonsustained ventricular tachycardia (cycle length ≤320 ms; ≥40 beats), atrioventricular block ≥IIb, and sustained ventricular tachycardia/ventricular fibrillation. The median follow-up period is 18 months with a minimum follow-up of 6 months. The effect of remote monitoring on clinical outcomes will be tested as secondary outcome measure (ClinicalTrials.gov NCT02594488).