- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075084
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs) (BIOSTREAM-ICM)
January 16, 2024 updated by: Biotronik SE & Co. KG
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
1400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabrina Hoche, Dr.
- Phone Number: 1337 +49 30 68905
- Email: biomonitor-registry@biotronik.com
Study Contact Backup
- Name: Silke Allgaier, Dr.
- Phone Number: 1244 +49 30 68905
- Email: biomonitor-registry@biotronik.com
Study Locations
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Adelaide, Australia
- Recruiting
- Royal Adelaide Hospital
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Contact:
- Dennis Lau, Dr.
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Adelaide, Australia
- Recruiting
- Integral Health
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Contact:
- Dennis Lau, Dr.
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Bordeaux, France
- Recruiting
- Hopital Saint-Andre
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Contact:
- Théo Caillol, Dr.
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Brest, France
- Recruiting
- Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
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Contact:
- Jacques Mansourati, Pr.
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Caen, France
- Recruiting
- Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
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Contact:
- Paul Milliez, Pr.
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Chambray-lès-Tours, France
- Recruiting
- Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
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Contact:
- Pierre Bertrand, Dr.
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Clermont-Ferrand, France
- Recruiting
- Hôpital Gabriel Montpied
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Contact:
- Romain Eschalier, Pr.
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Pessac Cedex, France
- Recruiting
- Hôpital Haut Lévêque (CHU)
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Contact:
- Sylvain Ploux, Pr.
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Strasbourg, France
- Recruiting
- Hopitaux Universitaires De Strasbourg
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Contact:
- Laurence Jesel-Morel, Dr.
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Ahaus, Germany
- Recruiting
- St. Marienkrankhaus Klinikum Westmünsterland GmbH
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Contact:
- Alessandro Cueno, Dr.
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Bad Nauheim, Germany
- Recruiting
- Kerckhoff-Klinik GmbH
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Contact:
- Andreas Hain, Dr.
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Bad Neustadt An Der Saale, Germany
- Recruiting
- Rhön-Klinikum
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Contact:
- Thomas Deneke, Prof. Dr.
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Berlin-Mitte, Germany
- Recruiting
- Deutsches Herzzentrum der Charité
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Contact:
- Verena Tscholl, Dr.
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Berlin-Steglitz, Germany
- Recruiting
- Deutsches Herzzentrum der Charité
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Contact:
- Martin Huemer, Dr.
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Dresden, Germany
- Recruiting
- Universitätsklinik an der Technischen Universität Dresden
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Contact:
- Thomas P. Gaspar, Dr.
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Erfurt, Germany
- Recruiting
- HELIOS Klinikum Erfurt
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Contact:
- Anja Schade, Dr.
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Herford, Germany
- Recruiting
- Klinikum Herford
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Contact:
- Klaus-Jürgen Gutleben, OA Dr.
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Leipzig, Germany
- Recruiting
- Helios Health Institute GmbH
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Contact:
- Sotirios Nedios, Dr.
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München, Germany
- Recruiting
- Klinikum rechts der Isar der Technischen Universität München
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Contact:
- Eimo Martens, Dr.
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Castrovillari, Italy
- Recruiting
- Ospedale Civile Ferrari
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Contact:
- Giovanni Bisignani, Dr.
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Torino, Italy
- Recruiting
- Ospedale Maria Vittoria
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Contact:
- Massimo Giammaria, Dr.
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Riga, Latvia, 1002
- Recruiting
- Pauls Stradins Clinical University Hospital
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Guimarães, Portugal
- Recruiting
- Hospital Senhora da Oliveira - Guimarães
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Contact:
- Victor M. Sanfins, Dr.
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Lisboa, Portugal
- Not yet recruiting
- Hospital De Santa Maria
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Contact:
- João de Sousa, Dr.
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Erandio, Spain
- Recruiting
- Centro Medico Teknon
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Contact:
- Antonio Berruezo Sanchez, Dr.
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Fuenlabrada, Spain
- Recruiting
- Hospital De Fuenlabrada
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Contact:
- Silvia Del Casillo, Dr.
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Vitoria-Gasteiz, Spain
- Recruiting
- Hospital Universitario de Araba
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Contact:
- Enrique Garcia, Dr.
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Wetzikon, Switzerland
- Recruiting
- GZO Spital Wetzikon
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Contact:
- Stephan Winnik, Dr.
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Zürich, Switzerland
- Recruiting
- Universitätsspital Zürich (USZ)
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Contact:
- Daniel Hofer, Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to diagnosis
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Device is intended to detect rare arrhythmias.
Time to detect this relevant arrhytmia will be recorded.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insertion procedure and success
Time Frame: 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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Information on the Insertion procedure (Operation time, handling of the BIOMONITOR incl.
incision and inserton tool); Success rate of insertions.
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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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensing and noise
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Inspection results of the insertion site
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Patient contentment regarding BIOMONITOR wearability
Time Frame: Data will be collected throughout the entire registry, i.e. until Febraury 2023 (Last patient out).
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Patients opinion about the wearing comfort (5-level-scale).
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Data will be collected throughout the entire registry, i.e. until Febraury 2023 (Last patient out).
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Device migration
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Assessement whether the BIOMONITOR migrates under the skin.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Diagnosis and clinical actions after arrhythmia detection
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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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.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Explantation / deactivation / exchange information of the BIOMONITOR
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Adverse Events
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Collect and analyze adverse events.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Device Deficiencies
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Collect and analyze device deficiencies.
Calculate rate (frequency) of device deficiencies.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Documentation of imaging techniques, if applied.
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Documentation if patients underwent any MRI examinations or mammography.
Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR.
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Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2019
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
March 30, 2028
Study Registration Dates
First Submitted
August 8, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 30, 2019
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Stroke
- Unconsciousness
- Consciousness Disorders
- Ischemic Stroke
- Atrial Fibrillation
- Bradycardia
- Tachycardia
- Syncope
Other Study ID Numbers
- HS061
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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