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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04075084
Other study ID # HS061
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 28, 2019
Est. completion date March 30, 2028

Study information

Verified date January 2024
Source Biotronik SE & Co. KG
Contact Sabrina Hoche, Dr.
Phone +49 30 68905
Email biomonitor-registry@biotronik.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1400
Est. completion date March 30, 2028
Est. primary completion date September 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Australia Integral Health Adelaide
Australia Royal Adelaide Hospital Adelaide
France Hôpital Saint-André Bordeaux
France Le Centre Hospitalier Universitaire de Brest (CHRU Brest) Brest
France Le Centre Hospitalier Universitaire de Caen (CHRU Caen) Caen
France Le Centre Hospitalier Universitaire de Tours (CHRU Tours) Chambray-lès-Tours
France Hôpital Gabriel Montpied Clermont-Ferrand
France Hôpital Haut Lévêque (CHU) Pessac Cedex
France Hôpitaux Universitaires de Strasbourg Strasbourg
Germany St. Marienkrankhaus Klinikum Westmünsterland GmbH Ahaus
Germany Kerckhoff-Klinik GmbH Bad Nauheim
Germany Rhön-Klinikum Bad Neustadt An Der Saale
Germany Deutsches Herzzentrum der Charité Berlin-Mitte
Germany Deutsches Herzzentrum der Charité Berlin-Steglitz
Germany Universitätsklinik an der Technischen Universität Dresden Dresden
Germany Helios Klinikum Erfurt Erfurt
Germany Klinikum Herford Herford
Germany Helios Health Institute GmbH Leipzig
Germany Klinikum rechts der Isar der Technischen Universität München München
Italy Ospedale Civile Ferrari Castrovillari
Italy Ospedale Maria Vittoria Torino
Latvia Pauls Stradins Clinical University Hospital Riga
Portugal Hospital Senhora da Oliveira - Guimarães Guimarães
Portugal Hospital de Santa Maria Lisboa
Spain Centro Médico Teknon Erandio
Spain Hospital de Fuenlabrada Fuenlabrada
Spain Hospital Universitario de Araba Vitoria-Gasteiz
Switzerland GZO Spital Wetzikon Wetzikon
Switzerland Universitätsspital Zürich (USZ) Zürich

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  Latvia,  Portugal,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Sensing and noise Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Inspection results of the insertion site Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale). Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Patient contentment regarding BIOMONITOR wearability Patients opinion about the wearing comfort (5-level-scale). Data will be collected throughout the entire registry, i.e. until Febraury 2023 (Last patient out).
Other Device migration Assessement whether the BIOMONITOR migrates under the skin. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Diagnosis and clinical actions after arrhythmia detection Documentation whether the BIOMONITOR helps to detect arrhythmias. Documentation of therapies used to treat these arrhythmias and whether the BIOMONITOR helps to monitor therapy success. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Explantation / deactivation / exchange information of the BIOMONITOR Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Adverse Events Collect and analyze adverse events. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Device Deficiencies Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Other Documentation of imaging techniques, if applied. Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Primary Time to diagnosis Device is intended to detect rare arrhythmias. Time to detect this relevant arrhytmia will be recorded. Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Secondary Insertion procedure and success Information on the Insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and inserton tool); Success rate of insertions. 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
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