RECRUITINGOBSERVATIONAL
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (20)
Integral Health
Adelaide, Australia
Royal Adelaide Hospital
Adelaide, Australia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 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