Trials / Completed
CompletedNCT02341534
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 802 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioMonitor | Patients will be implanted with the BioMonitor + Home Monitoring feature |
Timeline
- Start date
- 2015-08-07
- Primary completion
- 2021-11-03
- Completion
- 2021-11-03
- First posted
- 2015-01-19
- Last updated
- 2023-04-13
- Results posted
- 2023-04-13
Locations
59 sites across 14 countries: United States, Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Latvia, Netherlands, Poland, Slovakia, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02341534. Inclusion in this directory is not an endorsement.