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

Atrial Fibrillation Clinical Trial

— BIOSTREAM-ICM  

Official title:

BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075084
• Other study ID #: HS061
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bradycardia
• Cryptogenic Stroke
• Ischemic Stroke
• Syncope
• Tachycardia

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