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BIO|CONCEPT.Renamic Neo Study

NCT04350008 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2022-09-16

Study results available
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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.

Conditions

  • Medical Devices

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Biotronik Australia Pty Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2020-10-29
Completion
2020-10-29

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350008 on ClinicalTrials.gov