BIO|CONCEPT.Renamic Neo Study

BIO|CONCEPT.Renamic Neo

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.

Study Overview

• Status: Completed
• Conditions: Medical Devices
• Intervention / Treatment: Device: Renamic Neo programmer device, including software; PK-222-L ECG cable

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Auchenflower, Australia
    • GenesisCare Wesley
  • Bundaberg, Australia
    • GenesisCare Bundaberg
  • Canberra, Australia
    • The Canberra Hospital
  • Elizabeth Vale, Australia
    • Lyell McEwin Hospital (LMH)
  • Melbourne, Australia
    • Monash Medical Centre
  • Mulgrave, Australia
    • Mulgrave Private Hospital
  • New Lambton Heights, Australia
    • John Hunter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that are planned to receive or are already implanted with a programmable BIOTRONIK cardiac rhythm management (CRM) device.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases	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.	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).

Collaborators and Investigators

• Sponsor: Biotronik Australia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BA112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No