Clinical trial NCT04075084: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Official title: BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tachycardia
Atrial Fibrillation
Syncope
Bradycardia
Cryptogenic Stroke
Keywords: Implantable Cardiac Monitor
BIOMONITOR III
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.

Brief 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 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 written informed consent.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM

Primary outcomes:
measure: Time to diagnosis
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Secondary outcomes:
measure: Insertion procedure and success
timeFrame: It is considered that all patients are enrolled and subsequently inserted with the investigational device within 2 years after study start, i.e. until October 2021. Exchanges will be also considered for analysis
Other outcomes:
measure: Sensing and noise
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Inspection results of the insertion site
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Patient contentment regarding BIOMONITOR wearability
timeFrame: Data will be collected throughout the entire registry, i.e. until Febraury 2023 (Last patient out).
measure: Device migration
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Diagnosis and clinical actions after arrhythmia detection
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Explantation / deactivation / exchange information of the BIOMONITOR
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Adverse Events
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Device Deficiencies
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
measure: Documentation of imaging techniques, if applied.
timeFrame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Locations:
city: Adelaide
country: Australia
facility: Integral Health
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Brest
country: France
facility: Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
city: Caen
country: France
facility: Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
city: Chambray-lès-Tours
country: France
facility: Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Pessac Cedex
country: France
facility: Hôpital Haut Lévêque (CHU)
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Ahaus
country: Germany
facility: St. Marienkrankhaus Klinikum Westmünsterland GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön-Klinikum
city: Berlin-Mitte
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Berlin-Steglitz
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Dresden
country: Germany
facility: Universitätsklinik an der Technischen Universität Dresden
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Herford
country: Germany
facility: Klinikum Herford
city: Leipzig
country: Germany
facility: Helios Health Institute GmbH
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Castrovillari
country: Italy
facility: Ospedale Civile Ferrari
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimarães
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Erandio
country: Spain
facility: Centro Médico Teknon
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Araba
city: Wetzikon
country: Switzerland
facility: GZO Spital Wetzikon
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich (USZ)
Study officials:
References: