Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Recruiting · NCT04075084 · Observational (researchers observe without assigning treatment) · Lead sponsor: Biotronik SE & Co. KG
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
31 locations listed.
- Integral Health - Adelaide, Australia
- Royal Adelaide Hospital - Adelaide, Australia
- St. Marienkrankhaus Klinikum Westmünsterland GmbH - Ahaus, Germany
- Kerckhoff-Klinik GmbH - Bad Nauheim, Germany
- Rhön-Klinikum - Bad Neustadt an der Saale, Germany
- 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
- Ospedale Civile Ferrari - Castrovillari, Italy
- Le Centre Hospitalier Universitaire de Tours (CHRU Tours) - Chambray-lès-Tours, France
- Hôpital Gabriel Montpied - Clermont-Ferrand, France
- Universitätsklinik an der Technischen Universität Dresden - Dresden, Germany
- Centro Médico Teknon - Erandio, Spain
- Helios Klinikum Erfurt - Erfurt, Germany
- Hospital de Fuenlabrada - Fuenlabrada, Spain
- Unidade Local de Saúde do Alto Ave, E. P. E. - Guimarães, Portugal
- Klinikum Herford - Herford, Germany
- Helios Health Institute GmbH - Leipzig, Germany
- Unidade Local de Saúde de Santa Maria, E. P. E. - Lisbon, Portugal
- Deutsches Herzzentrum der Charité - Mitte, Germany
- Klinikum rechts der Isar der Technischen Universität München - München, Germany
- Hôpital Haut Lévêque (CHU) - Pessac, France
- Pauls Stradins Clinical University Hospital - Riga, Latvia
- Deutsches Herzzentrum der Charité - Steglitz, Germany
- Hôpitaux Universitaires de Strasbourg - Strasbourg, France
- Ospedale Maria Vittoria - Torino, Italy
- Hospital Álvaro Cunqueiro - Vigo, Spain
- Hospital Universitario de Araba - Vitoria-Gasteiz, Spain
- GZO Spital Wetzikon - Wetzikon, Switzerland
- Universitätsspital Zürich (USZ) - Zurich, Switzerland
- Nemocnice Ceske Budejovice, a.s. - České Budějovice, Czechia