BIO|STREAM.ICM Obesity

N/ACompletedNCT04198220

Biotronik SE & Co. KG30 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Tachycardia Atrial Atrial Fibrillation Syncope Bradycardia Cryptogenic Stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedale Civile Ferrari

Castrovillari, Italy

Outcomes

Primary Outcomes

R-wave amplitude

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

Time frame: 3 month

Secondary Outcomes

Amount of 'noise burden'

Measurement of amount of 'noise burden' during the study period

Time frame: 3 month

P-wave visibility

Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation

Time frame: 1 month and 3 month

Data from ClinicalTrials.gov

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