Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Time to diagnosis
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
Time frame
The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.Secondary outcomes
1
Insertion procedure and success
Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions.
Time frame
Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.Other outcomes
1
Sensing and noise
Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR.
Time frame
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).2
Inspection results of the insertion site
Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).
Time frame
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).3
Patient contentment regarding BIOMONITOR wearability
Patients opinion about the wearing comfort (5-level-scale).
Time frame
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).4
Device migration
Assessement whether the BIOMONITOR migrates under the skin.
Time frame
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov