Status:
COMPLETED
BIO|CONCEPT.BIOMONITOR III
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Atrial Fibrillation
Syncope
Eligibility:
All Genders
18-90 years
Phase:
NA
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 se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients implanted with ICD or pacemaker.
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
- Patient is participating in another interventional clinical investigation
- Patient´s life-expectancy is less than 6 months.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03850327
Start Date
March 8 2019
End Date
October 6 2019
Last Update
May 27 2021
Active Locations (7)
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1
HeartCare Partners - Wesley Testing
Auchenflower, Queensland, Australia, 4066
2
Bundaberg Cardiology
Bundaberg, Queensland, Australia, 4670
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
4
HeartCare Victoria - Doncaster
Balwyn, Victoria, Australia, 3103