NCT04198220

BIO|STREAM.ICM Obesity

BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tachycardia Atrial
• Atrial Fibrillation
• Syncope
• Bradycardia
• Cryptogenic Stroke

Timeline

• Start date: 2020-09-17
• Primary completion: 2021-05-26
• Completion: 2021-09-01
• First posted: 2019-12-13
• Last updated: 2021-10-22

Locations

1 site across 1 country: Italy