Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02341534
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIO-GUARD-MI
Brief Summary:
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: