NCT04075084RecruitingNot Applicable
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Biotronik SE & Co. KG30 sites in 9 countries1,400 target enrollmentStarted: October 28, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 1,400
- Locations
- 30
- Primary Endpoint
- Time to diagnosis
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Time to diagnosis
Time Frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
Secondary Outcomes
- Insertion procedure and success(Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.)
Investigators
Study Sites (30)
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