Status:
COMPLETED
BIO|CONCEPT.Renamic Neo Study
Lead Sponsor:
Biotronik Australia Pty Ltd.
Conditions:
Medical Devices
Eligibility:
All Genders
18+ years
Brief Summary
The BIO\|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.
Eligibility Criteria
Inclusion
- Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device.
- Patient is able to understand the nature of the study and provides written informed consent.
Exclusion
- Patient is implanted with a Stratos pacemaker.
- Patient is planned for implant exchange or upgrade.
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 29 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04350008
Start Date
June 8 2020
End Date
October 29 2020
Last Update
September 16 2022
Active Locations (8)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
GenesisCare Wesley
Auchenflower, Australia
3
GenesisCare Bundaberg
Bundaberg, Australia
4
The Canberra Hospital
Canberra, Australia