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BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

NCT02341534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2023-04-13

Study results available
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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.

Conditions

Interventions

DEVICE

BioMonitor

Patients will be implanted with the BioMonitor + Home Monitoring feature

Sponsors & Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

    collaborator OTHER

  • Qmed Consulting A/S

    collaborator INDUSTRY

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Christian Jons, Doctor · Rigshospitalet; Denmark; Copenhagen

  • Steffen Behrens, Professor · Vivantes Humboldt Klinikum, Germany, Berlin

  • Poul Erik Bloch Thomsen, Professor · Aalborg University Hospital, Denmark, Aalborg

  • Peter Sogaard, Professor · Aalborg University Hospital, Denmark, Aalborg

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2021-11-03
Completion
2021-11-03
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341534 on ClinicalTrials.gov