BIO|CONCEPT.Renamic Neo Study

NCT04350008 | Completed Results

• 1 other identifier: BA112
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

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

  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).

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik Australia Pty Ltd.: lead

Study Sites (8)

Royal Adelaide Hospital

Adelaide, Australia

Location

GenesisCare Wesley

Auchenflower, Australia

Location

GenesisCare Bundaberg

Bundaberg, Australia

Location

The Canberra Hospital

Canberra, Australia

Location

Lyell McEwin Hospital (LMH)

Elizabeth Vale, Australia

Location

Monash Medical Centre

Melbourne, Australia

Location

Mulgrave Private Hospital

Mulgrave, Australia

Location

John Hunter Hospital

New Lambton Heights, Australia

Location

Results Point of Contact

• Title: Director Clinical Project Management
• Organization: BIOTRONIK SE & Co.KG

mathias.freudigmann@biotronik.com

+49 30 68905

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: June 8, 2020
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8)