BIO|CONCEPT.BIOMONITOR III

Biotronik SE & Co. KG7 sites in 1 country48 target enrollmentMarch 8, 2019

ConditionsAtrial Fibrillation Syncope Tachyarrhythmia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Biotronik SE & Co. KG
Enrollment: 48
Locations: 7
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.

Registry

clinicaltrials.gov

Start Date

March 8, 2019

End Date

October 6, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
•Patient is able to understand the nature of study and has provided written informed consent.
•Patient is willing and able to perform all follow up visits at the study site.
•Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.