Study Results
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View full resultsBasic Information
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COMPLETED
110 participants
OBSERVATIONAL
2020-06-08
2020-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Renamic Neo programmer device, including software; PK-222-L ECG cable
Patients were enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients were included for follow-ups only. Implants were programmed and interrogated by using the investigational devices.
Eligibility Criteria
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Inclusion Criteria
* Patient is able to understand the nature of the study and provides written informed consent.
Exclusion Criteria
* Patient is planned for implant exchange or upgrade.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
18 Years
ALL
No
Sponsors
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Biotronik Australia Pty Ltd.
INDUSTRY
Responsible Party
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Locations
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Royal Adelaide Hospital
Adelaide, , Australia
GenesisCare Wesley
Auchenflower, , Australia
GenesisCare Bundaberg
Bundaberg, , Australia
The Canberra Hospital
Canberra, , Australia
Lyell McEwin Hospital (LMH)
Elizabeth Vale, , Australia
Monash Medical Centre
Melbourne, , Australia
Mulgrave Private Hospital
Mulgrave, , Australia
John Hunter Hospital
New Lambton Heights, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BA112
Identifier Type: -
Identifier Source: org_study_id
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