BIO|CONCEPT.Renamic Neo Study

Medical Devices Clinical Trial

Official title:

BIO|CONCEPT.Renamic Neo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350008
• Other study ID #: BA112
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: October 29, 2020

Study information

• Verified date: May 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medical Devices

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik Australia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).