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NCT04198220 Clinical Trial

BIO|STREAM.ICM Obesity

Atrial Fibrillation Clinical Trial

Official title:
BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04198220
Other study ID # HS064
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2020
Est. completion date September 1, 2021

Study information
Verified date December 2020
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 1, 2021
Est. primary completion date May 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedale Civile Ferrari Castrovillari

Sponsors (1)
Lead Sponsor Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other Incidence of arrhythmias Assessment of the incidence of arrhythmias in obese patients implanted with an ICM 3 month
Primary R-wave amplitude R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30 3 month
Secondary Amount of 'noise burden' Measurement of amount of 'noise burden' during the study period 3 month
Secondary P-wave visibility Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation 1 month and 3 month
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