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OpenTrials
Completed

NCT Number: NCT04350008

BIO|CONCEPT.Renamic Neo Study

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.

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Key information

Conditions

Medical Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Renamic Neo programmer device, including software; PK-222-L ECG cable

Device

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.

Primary outcomes

  1. Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases

    Time frame: Patients participated from (I) implantation until the pre-hospital discharge (usually 1-2 days) or (II) only for the in-office follow-up (usually 1 day).

    The number of Adverse Device Effects (ADE) and Device Deficiencies (DD) that occured in patients, users or other persons during the use of the Renamic Neo programmer at implantation, pre-hospital discharge and during the on-site follow-up was evaluated. The investigator was asked to report any ADEs or DD that occurred during implantations and follow-ups. All Adverse Device Effects (ADE) related to the investigational device and only Device Deficiencies (DD) that were determined to bear the potential for a medical occurrence were prespecified to be collected.

Sponsors and collaborators

Lead sponsor

Biotronik Australia Pty Ltd.

Industry

Registry information

Official study title

BIO|CONCEPT.Renamic Neo

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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