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Recruiting NCT04075084

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Conditions: Tachycardia Atrial Fibrillation Syncope Bradycardia Cryptogenic Stroke

Sponsor: Biotronik SE & Co. KG

trial.available_in: БГ
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.
Who can participate
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 9
Australia (1)
Integral Health
Adelaide
Czech Republic (1)
Nemocnice Ceske Budejovice, a.s.
České Budějovice
France (1)
Hôpital Saint-André
Bordeaux
COMPLETED
Germany (1)
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus
Italy (1)
Ospedale Civile Ferrari
Castrovillari
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Portugal (1)
Unidade Local de Saúde do Alto Ave, E. P. E.
Guimarães
Spain (1)
Centro Médico Teknon
Erandio
Switzerland (1)
GZO Spital Wetzikon
Wetzikon
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.10.2019
Completion date
30.08.2027
Registry ID
NCT04075084
Source
anzctr
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