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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04198220
Study type Observational
Source Biotronik SE & Co. KG
Contact
Status Completed
Phase
Start date September 17, 2020
Completion date September 1, 2021

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