Study ID: Bio|Guard-MI
Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction
This multi-center, prospective, randomized study is investigating if continuous arrhythmia monitoring and detection using BioMonitor, an implantable cardiac monitor, decreases the risk of major adverse cardiovascular events in patients who have had a heart attack and are deemed at increased risk for cardiac arrhythmias.
Patients randomized to the BioMonitor arm will receive the implantable cardiac monitor being studied (BioMonitor), which has a remote monitoring function. If the device detects and reports an arrhythmia, patients will be appropriately examined and treated.
Patients randomized to the control arm will receive the best proven treatment, but no implantable cardiac monitor.
The study’s primary objective is to investigate whether the early diagnosis of cardiac arrhythmias, provided by the BioMonitor in connection with remote monitoring, and the consequent treatment of patients will decrease their risk for major adverse cardiovascular events.
Eligible patients have had a myocardial infarction with a CHA2DS2-VASc score of ≥ 4 in men and ≥ 5 in women and left ventricular ejection fraction of > 35%.
- Must have been diagnosed with myocardial infarction, have preserved left ventricular function and be at increased risk for cardiac arrhythmia
- Must not be on permanent oral anticoagulation treatment for atrial fibrillation
- Must have CHADS2-VASC >4 in men and >5 in women