RecruitingNCT04075084
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Sponsor
Biotronik SE & Co. KG
Enrollment
1,400 participants
Start Date
Oct 28, 2019
Study Type
OBSERVATIONAL
Conditions
Summary
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
- Patient is able to understand the nature of the registry and to provide written informed consent.
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria3
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
- Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM
Locations(31)
View Full Details on ClinicalTrials.gov
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NCT04075084
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