Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Last updated: June 21, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Low Blood Pressure (Hypotension)

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04075084
HS061
  • Ages > 18
  • All Genders

Study Summary

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)

  • Patient is able to understand the nature of the registry and to provide writteninformed consent.

  • Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIKHome Monitoring concept.

Exclusion

Exclusion Criteria:

  • Patient is pregnant or breast feeding.

  • Patient is less than 18 years old.

  • Patient is participating in another interventional clinical investigation other thanthe submodules of BIO|STREAM.ICM

Study Design

Total Participants: 1400
Study Start date:
October 28, 2019
Estimated Completion Date:
March 30, 2028

Connect with a study center

  • Integral Health

    Adelaide,
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Hôpital Saint-André

    Bordeaux,
    France

    Completed

  • Le Centre Hospitalier Universitaire de Brest (CHRU Brest)

    Brest,
    France

    Active - Recruiting

  • Le Centre Hospitalier Universitaire de Caen (CHRU Caen)

    Caen,
    France

    Active - Recruiting

  • Le Centre Hospitalier Universitaire de Tours (CHRU Tours)

    Chambray-lès-Tours,
    France

    Active - Recruiting

  • Hôpital Gabriel Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Hôpital Haut Lévêque (CHU)

    Pessac Cedex,
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • St. Marienkrankhaus Klinikum Westmünsterland GmbH

    Ahaus,
    Germany

    Active - Recruiting

  • Kerckhoff-Klinik GmbH

    Bad Nauheim,
    Germany

    Active - Recruiting

  • Rhön-Klinikum

    Bad Neustadt An Der Saale,
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum der Charité

    Berlin-Mitte,
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum der Charité

    Berlin-Steglitz,
    Germany

    Active - Recruiting

  • Universitätsklinik an der Technischen Universität Dresden

    Dresden,
    Germany

    Active - Recruiting

  • Helios Klinikum Erfurt

    Erfurt,
    Germany

    Active - Recruiting

  • Klinikum Herford

    Herford,
    Germany

    Active - Recruiting

  • Helios Health Institute GmbH

    Leipzig,
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der Technischen Universität München

    München,
    Germany

    Active - Recruiting

  • Ospedale Civile Ferrari

    Castrovillari,
    Italy

    Active - Recruiting

  • Ospedale Maria Vittoria

    Torino,
    Italy

    Active - Recruiting

  • Pauls Stradins Clinical University Hospital

    Riga, 1002
    Latvia

    Active - Recruiting

  • Hospital Senhora da Oliveira - Guimarães

    Guimarães,
    Portugal

    Active - Recruiting

  • Hospital de Santa Maria

    Lisboa,
    Portugal

    Site Not Available

  • Centro Médico Teknon

    Erandio,
    Spain

    Active - Recruiting

  • Hospital de Fuenlabrada

    Fuenlabrada,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo,
    Spain

    Active - Recruiting

  • Hospital Universitario de Araba

    Vitoria-Gasteiz,
    Spain

    Active - Recruiting

  • GZO Spital Wetzikon

    Wetzikon,
    Switzerland

    Completed

  • Universitätsspital Zürich (USZ)

    Zürich,
    Switzerland

    Active - Recruiting

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