Skip to main content
OpenTrials
Completed

NCT Number: NCT04198220

BIO|STREAM.ICM Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tachycardia Atrial Arrhythmias, Cardiac Atrial Fibrillation Body Weight Bradycardia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Cryptogenic Stroke Heart Diseases Ischemic Stroke Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Syncope Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Civile Ferrari

Castrovillari, 87012, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. R-wave amplitude

    Time frame: 3 month

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

Secondary outcomes

  1. Amount of 'noise burden'

    Time frame: 3 month

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

  2. P-wave visibility

    Time frame: 1 month and 3 month

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

Other outcomes

  1. Incidence of arrhythmias

    Time frame: 3 month

    Assessment of the incidence of arrhythmias in obese patients implanted with an ICM

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2019
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.