BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction (BIO-GUARD-MI)

Biotronik

Status: Completed

Conditions: Myocardial Infarction Old; Myocardial Infarction, Acute; Myocardial Infarction

Treatments: Device: BioMonitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02341534

Preserved Ejection Fraction (Other Identifier)

Implantable Cardiac Device (Other Identifier)

HS058

ICM (Other Identifier)

Loop Recorder (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 802 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

802 participants in 2 patient groups

BioMonitor arm

Other group

Description:

BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)

Treatment:

Device: BioMonitor

Control arm

No Intervention group

Description:

Control group (standard of care)