Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
BIOSTREAM-ICM
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
1 other identifier
observational
1,400
9 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
October 1, 2025
August 1, 2025
7.6 years
August 8, 2019
September 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to diagnosis
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Secondary Outcomes (1)
Insertion procedure and success
Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
Other Outcomes (9)
Sensing and noise
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Inspection results of the insertion site
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Patient contentment regarding BIOMONITOR wearability
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
- +6 more other outcomes
Eligibility Criteria
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Integral Health
Adelaide, Australia
Royal Adelaide Hospital
Adelaide, Australia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 37001, Czechia
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, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Rhön-Klinikum
Bad Neustadt an der Saale, Germany
Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Klinikum Herford
Herford, Germany
Helios Health Institute GmbH
Leipzig, Germany
Deutsches Herzzentrum der Charité
Mitte, Germany
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Deutsches Herzzentrum der Charité
Steglitz, Germany
Ospedale Civile Ferrari
Castrovillari, Italy
Ospedale Maria Vittoria
Torino, Italy
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Unidade Local de Saúde do Alto Ave, E. P. E.
Guimarães, Portugal
Unidade Local de Saúde de Santa Maria, E. P. E.
Lisbon, Portugal
Centro Médico Teknon
Erandio, Spain
Hospital de Fuenlabrada
Fuenlabrada, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
GZO Spital Wetzikon
Wetzikon, Switzerland
Universitätsspital Zürich (USZ)
Zurich, Switzerland
Related Publications (1)
Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.
PMID: 37025684DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 30, 2019
Study Start
October 28, 2019
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
October 1, 2025
Record last verified: 2025-08