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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

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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