BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Biotronik SE & Co. KG30 sites in 9 countries1,400 target enrollmentOctober 28, 2019

ConditionsTachycardia Atrial Fibrillation Syncope Bradycardia Cryptogenic Stroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Tachycardia
Sponsor: Biotronik SE & Co. KG
Enrollment: 1400
Locations: 30
Primary Endpoint: Time to diagnosis
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 28, 2019

End Date

August 30, 2027

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

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