Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.
Giovanni Bisignani, Silvana De Bonis, Bertrand Pierre...
https://pubmed.ncbi.nlm.nih.gov/37025684Actively Recruiting
Age: 18Years +
All Genders
ID04075084
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Led by Biotronik SE & Co. KG · Updated on 2025-10-01
1400
Participants Needed
31
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term outcomes, performance, and ongoing safety of the BIOMONITOR III and its possible successors in everyday clinical use. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, or cryptogenic stroke. The study is designed as an observational registry, allowing additional scientific investigations with minimal extra effort for participants and study sites. Participants will receive a BIOTRONIK Implantable Cardiac Monitor (ICM) and will use the CardioMessenger device to support the BIOTRONIK Home Monitoring system. The registry monitors patients under routine clinical care without introducing experimental treatments or interventions. Data collection includes the insertion procedure and success rate of the device, as well as the time taken to reach a relevant diagnosis starting from device implantation. Throughout the study, participants will be observed during their regular clinical care visits. Researchers will collect information on device performance, safety, and diagnostic timelines. The study will continue until August 30, 2027, tracking patient outcomes over this extended period. Participation involves consenting to the use of home monitoring technology and agreeing to data collection related to the implanted device and clinical events.
CONDITIONS
Brief Title
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patient is pregnant or breastfeeding
- Patient is less than 18 years old
- Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of insertion
Participants receive the BIOTRONIK Implantable Cardiac Monitor device as part of routine clinical care.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants who undergo routine care are observed through the BIOTRONIK Home Monitoring system to track clinical outcomes and device performance.
Ongoing remote monitoring with periodic in-person follow-ups as part of routine care
Trial Site Locations
Total: 31 locations
1
Integral Health
Adelaide, Australia
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, Australia
Completed
3
Nemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia, 37001
Actively Recruiting
4
Hôpital Saint-André
Bordeaux, France
Completed
5
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
Brest, France
Actively Recruiting
6
Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
Caen, France
Actively Recruiting
7
Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
Chambray-lès-Tours, France
Active, Not Recruiting
8
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
9
Hôpital Haut Lévêque (CHU)
Pessac, France
Actively Recruiting
10
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Actively Recruiting
11
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, Germany
Actively Recruiting
12
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Actively Recruiting
13
Rhön-Klinikum
Bad Neustadt an der Saale, Germany
Active, Not Recruiting
14
Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
Completed
15
Helios Klinikum Erfurt
Erfurt, Germany
Actively Recruiting
16
Klinikum Herford
Herford, Germany
Actively Recruiting
17
Helios Health Institute GmbH
Leipzig, Germany
Actively Recruiting
18
Deutsches Herzzentrum der Charité
Mitte, Germany
Actively Recruiting
19
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Active, Not Recruiting
20
Deutsches Herzzentrum der Charité
Steglitz, Germany
Actively Recruiting
21
Ospedale Civile Ferrari
Castrovillari, Italy
Actively Recruiting
22
Ospedale Maria Vittoria
Torino, Italy
Actively Recruiting
23
Pauls Stradins Clinical University Hospital
Riga, Latvia, 1002
Actively Recruiting
24
Unidade Local de Saúde do Alto Ave, E. P. E.
Guimarães, Portugal
Actively Recruiting
25
Unidade Local de Saúde de Santa Maria, E. P. E.
Lisbon, Portugal
Actively Recruiting
26
Centro Médico Teknon
Erandio, Spain
Actively Recruiting
27
Hospital de Fuenlabrada
Fuenlabrada, Spain
Active, Not Recruiting
28
Hospital Álvaro Cunqueiro
Vigo, Spain
Actively Recruiting
29
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
Actively Recruiting
30
GZO Spital Wetzikon
Wetzikon, Switzerland
Completed
31
Universitätsspital Zürich (USZ)
Zurich, Switzerland
Actively Recruiting
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Research Team
S
Sabrina Hoche, Dr.
D
Dörte Vossmeyer, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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