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Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
RECRUITINGSponsored by Biotronik SE & Co. KG
Actively Recruiting
SponsorBiotronik SE & Co. KG
Started2019-10-28
Est. completion2027-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04075084
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions6
Atrial FibrillationBradycardiaCryptogenic StrokeHeart DiseaseSyncopeTachycardia
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Actively Recruiting
SponsorBiotronik SE & Co. KG
Started2019-10-28
Est. completion2027-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04075084