BIO|CONCEPT.Renamic Neo Study

NCT ID: NCT04350008

Last Updated: 2022-09-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2020-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Medical Devices

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik Australia Pty Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Adelaide Hospital

Adelaide, , Australia

Site Status

GenesisCare Wesley

Auchenflower, , Australia

Site Status

GenesisCare Bundaberg

Bundaberg, , Australia

Site Status

The Canberra Hospital

Canberra, , Australia

Site Status

Lyell McEwin Hospital (LMH)

Elizabeth Vale, , Australia

Site Status

Monash Medical Centre

Melbourne, , Australia

Site Status

Mulgrave Private Hospital

Mulgrave, , Australia

Site Status

John Hunter Hospital

New Lambton Heights, , Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BA112

Identifier Type: -

Identifier Source: org_study_id

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