BIO Guard-MI

BIOGUARD-MI

BIO Monitoring in Patients with Preserved Left Ventricular Function After Diagnosed Acute Myocardial Infarction

Study Design

  • Randomized, controlled, parallel-group, open, prospective, multi-center, international study
  • Investigates whether the early diagnosis of cardiac arrhythmias, provided by the BioMonitor in connection with remote monitoring, and the consequent treatment of the patient will decrease the risk to experience a major adverse cardiovascular event (MACE) in patients with AMI, LVEF > 35 % and modified CHADS2-score ≥ 3
  • 2,900 patients planned – This study is ongoing
1° Endpoints
  • Time to first major cardiac adverse event (MACE)
  • MACE is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons
Sample Size
  • 2,900 patients
Inclusion Criteria
  • History of AMI according to guidelines
  • CHADS2-score ≥ 3 with modified age-variable ≥ 65 years
  • LVEF > 35 %
  • Patient accepts activation of Home Monitoring®
  • Patient has provided written informed consent
Main Exclusion Criteria
  • Platelet count 3 or patients with haemorrhagic diathesis
  • Permanent oral anticoagulation treatment for atrial fibrillation
  • Indication for chronic renal dialysis
  • Pacemaker or ICD implanted or indication for implantation
  • Previously documented sustained VT
  • Parkinson's disease
  • Life expectancy
  • Participation in another interventional clinical investigation
Devices
  • BioMonitor or CE-approved successors
Follow-Up
  • Depending on date of enrollment from 2 until 6 years
Study Duration
  • study start date Aug 2015 - 6 years planned
Reference no.
  • NCT02341534
Steering Committee
  • Dr. Christian Jons (Rigshospitalet, Denmark)
  • Prof. Dietmar Bänsch (Universitätsmedizin Rostock, Germany)
  • Professor Peter Sogaard (Aalborg University Hospital, Denmark)
  • Prof. Poul Erik Bloch Thomsen (Denmark)

Imagem
BioMonitor 2

Arrhythmia Monitoring

BIOTRONIK offers accurate arrhythmia detection with Insertable Cardiac Monitors.