BIO|CONCEPT.Renamic Neo Study

Completed

• Conditions: Medical Devices

• Registration Number: NCT04350008
• Lead Sponsor: Biotronik Australia Pty Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2020-05
• Study Start: 2020-06-08
• Primary Completion: 2020-10-29
• Study Completion: 2020-10-29
• Results First Submitted: 2022-03-15
• Results First Submitted QC: 2022-08-22
• Last Update Submitted: 2022-08-22
• Results First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (8)

GenesisCare Bundaberg; 🇦🇺 Bundaberg, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

GenesisCare Wesley; 🇦🇺 Auchenflower, Australia

John Hunter Hospital; 🇦🇺 New Lambton Heights, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Australia

Lyell McEwin Hospital (LMH); 🇦🇺 Elizabeth Vale, Australia

Mulgrave Private Hospital; 🇦🇺 Mulgrave, Australia

The Canberra Hospital; 🇦🇺 Canberra, Australia