Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tachycardia, Atrial Fibrillation, Syncope, Bradycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Czechia, France, Germany, Italy +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Overview
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.
Primary outcome measures
- Time to diagnosis [Time frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.]
Secondary outcome measures (1)
- Insertion procedure and success [Time frame: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 10 centers
- St. Marienkrankhaus Klinikum Westmünsterland GmbH — Ahaus
- Kerckhoff-Klinik GmbH — Bad Nauheim
- Rhön-Klinikum — Bad Neustadt an der Saale
- Universitätsklinik an der Technischen Universität Dresden — Dresden
- Helios Klinikum Erfurt — Erfurt
- Klinikum Herford — Herford
- Helios Health Institute GmbH — Leipzig
- Deutsches Herzzentrum der Charité — Mitte
- … and 2 more centers
France · 7 centers
- Hôpital Saint-André — Bordeaux
- Le Centre Hospitalier Universitaire de Brest (CHRU Brest) — Brest
- Le Centre Hospitalier Universitaire de Caen (CHRU Caen) — Caen
- Le Centre Hospitalier Universitaire de Tours (CHRU Tours) — Chambray-lès-Tours
- Hôpital Gabriel Montpied — Clermont-Ferrand
- Hôpital Haut Lévêque (CHU) — Pessac
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Spain · 4 centers
- Centro Médico Teknon — Erandio
- Hospital de Fuenlabrada — Fuenlabrada
- Hospital Álvaro Cunqueiro — Vigo
- Hospital Universitario de Araba — Vitoria-Gasteiz
Australia · 2 centers
- Integral Health — Adelaide
- Royal Adelaide Hospital — Adelaide
Italy · 2 centers
- Ospedale Civile Ferrari — Castrovillari
- Ospedale Maria Vittoria — Torino
Portugal · 2 centers
- Unidade Local de Saúde do Alto Ave, E. P. E. — Guimarães
- Unidade Local de Saúde de Santa Maria, E. P. E. — Lisbon
Switzerland · 2 centers
- GZO Spital Wetzikon — Wetzikon
- Universitätsspital Zürich (USZ) — Zurich
Czechia · 1 center
- Nemocnice Ceske Budejovice, a.s. — České Budějovice
Latvia · 1 center
- Pauls Stradins Clinical University Hospital — Riga
Publications
- 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 PMID 37025684
Identifiers
NCT: NCT04075084 · HS061