Clincosm LogoSign in Get a demo

BIO|STREAM.ICM Obesity

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT04198220
Collaborator
(none)
30
Enrollment
1
Location
11.5
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry
    Actual Study Start Date :
    Sep 17, 2020
    Actual Primary Completion Date :
    May 26, 2021
    Actual Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. R-wave amplitude [3 month]

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

    Secondary Outcome Measures

    1. Amount of 'noise burden' [3 month]

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

    2. P-wave visibility [1 month and 3 month]

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

    Other Outcome Measures

    1. Incidence of arrhythmias [3 month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale Civile Ferrari Castrovillari Italy 87012

    Sponsors and Collaborators

    • Biotronik SE & Co. KG

    Investigators

    • Principal Investigator: Giovanni Bisignani, Dr., Ospedale Civile Ferrari

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biotronik SE & Co. KG
    ClinicalTrials.gov Identifier:
    NCT04198220
    Other Study ID Numbers:
    • HS064
    First Posted:
    Dec 13, 2019
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biotronik SE & Co. KG
    Obesity
    BIOMONITOR
    BIOMONITOR III
    Syncope
    Cryptogenic stroke
    Atrial Fibrillation
    Additional relevant MeSH terms:
    Syncope
    Ischemic Stroke
    Atrial Fibrillation
    Tachycardia
    Bradycardia
    Obesity

    Study Results

    No Results Posted as of Oct 22, 2021