Atrial Fibrillation, Bradycardia, Cryptogenic Stroke, Syncope, Tachycardia Atrial
Conditions
Keywords
Obesity, BIOMONITOR, BIOMONITOR III, Syncope, Cryptogenic stroke, Atrial Fibrillation
Brief summary
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
Detailed description
This submodule of the BIO\|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI \>30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.
Interventions
None listed
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is already enrolled in the BIO\|STREAM.ICM registry * Patient BMI \> 30
Exclusion criteria
* Patient clinically indicated for or already implanted with another cardiac active device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R-wave amplitude | 3 month | R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of 'noise burden' | 3 month | Measurement of amount of 'noise burden' during the study period |
| P-wave visibility | 1 month and 3 month | Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of arrhythmias | 3 month | Assessment of the incidence of arrhythmias in obese patients implanted with an ICM |
Countries
Italy
Outcome results
None listed