Atrial Fibrillation, Bradycardia, Cryptogenic Stroke, Syncope, Tachycardia
Conditions
Keywords
Implantable Cardiac Monitor, BIOMONITOR III, BIOMONITOR IV
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.
Interventions
None listed
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to diagnosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Insertion procedure and success | Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion. | Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient contentment regarding BIOMONITOR wearability | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Patients opinion about the wearing comfort (5-level-scale). |
| Device migration | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Assessement whether the BIOMONITOR migrates under the skin. |
| Diagnosis and clinical actions after arrhythmia detection | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Documentation whether the BIOMONITOR helps to detect arrhythmias. Documentation of therapies used to treat these arrhythmias and whether the BIOMONITOR helps to monitor therapy success. |
| Sensing and noise | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR. |
| Adverse Events | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Collect and analyze adverse events. |
| Device Deficiencies | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies. |
| Documentation of imaging techniques, if applied. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR. |
| Explantation / deactivation / exchange information of the BIOMONITOR | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure. |
| Inspection results of the insertion site | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale). |
Countries
Australia, Czechia, France, Germany, Italy, Latvia, Portugal, Spain, Switzerland
Contacts
Primary ContactSabrina Hoche, Dr.
Backup ContactDörte Vossmeyer, Dr.
Outcome results
None listed