BIO|STREAM.ICM Obesity

Completed

• Conditions: Atrial Fibrillation; Cryptogenic Stroke; Bradycardia; Tachycardia Atrial; Syncope

• Registration Number: NCT04198220
• Lead Sponsor: Biotronik SE & Co. KG

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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-09-17
• Status Verified: 2020-12
• Primary Completion: 2021-05-26
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R-wave amplitude	3 month	R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Civile Ferrari; 🇮🇹 Castrovillari, Italy