Status:
COMPLETED
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Tachyarrhythmia
Atrial Fibrillation (AF)
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even...
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 the study and able to provide written informed consent.
- Patient is willing and able to perform all follow-up visits at the investigational site.
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion
- Patient is implanted with an ICD or pacemaker.
- Patient is pregnant or breast-feeding.
- Patient is less than 18 years old.
- Patient's life-expectancy is less than 12 months.
- Patient is participating in another interventional clinical investigation.
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT04025710
Start Date
October 17 2019
End Date
April 6 2022
Last Update
November 27 2024
Active Locations (27)
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1
GenesisCare Wesley
Auchenflower, Australia
2
GenesisCare Bundaberg
Bundaberg, Australia
3
GenesisCare Doncaster
Doncaster East, Australia
4
Canberra Heart Rhythm Clinic
Garran, Australia