Lancaster, South Carolina 29720


Purpose:

The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.


Study summary:

Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM; BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and reports an arrhythmia, patients will be appropriately examined and treated. Patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.


Criteria:

Inclusion Criteria: - Patient has a history of MI according to guidelines - CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women - LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment - Patient accepts activation of Home Monitoring® - Patient is able to understand the nature of the clinical study and has provided written informed consent Exclusion Criteria: - Platelet count < 90.000 per mm3 or patients with hemorrhagic diathesis - Permanent oral anticoagulation treatment for atrial fibrillation - Indication for chronic renal dialysis - Pacemaker or ICD implanted or indication for implantation - Parkinson's disease - Life expectancy < 1 year - Participation in another interventional clinical Investigation - Age < 18 years - Woman who are pregnant or breast feeding


NCT ID:

NCT02341534


Primary Contact:

Study Chair
Christian Jons, Doctor
Rigshospitalet; Denmark; Copenhagen

Sascha Mrosk
Phone: +49 (0) 30 68905-1308
Email: bio-guard-mi@biotronik.com


Backup Contact:

Email: bio-guard-mi@biotronik.com
Maike Kluding
Phone: +49 (0) 30 68905-1371


Location Contact:

Lancaster, South Carolina 29720
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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