NCT04350008

BIO|CONCEPT.Renamic Neo Study

Completed Results posted Last updated 16 September 2022

What this trial tests

trial testing Renamic Neo programmer device, including software; PK-222-L ECG cable in Medical Devices in 110 participants. Completed in 29 October 2020.

Timeline

8 June 2020

Primary endpoint
29 October 2020

29 October 2020

Quick facts

Lead sponsor	Biotronik Australia Pty Ltd.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	110
Start date	8 June 2020
Primary completion	29 October 2020
Estimated completion	29 October 2020
Sites	8 locations across Australia

Drugs / interventions tested

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

Conditions studied

• Medical Devices — all drugs for Medical Devices →

Sponsor

Biotronik Australia Pty Ltd. — full company profile →

Who can join

18 and older, any sex, with Medical Devices. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Implantation and Follow-up Use Cases	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Implantations (Days): Mean: 1.0; SD: SD:1.6 Follow-up (Days) : Mean:1.1 SD: 6.0. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Implantation and Follow-up Use Cases

Serious: 0/110 (0%)

Deaths: 0/110

Other adverse events (1 terms — click to expand)

Reaction	System	Implantation and Follow-up…
Complete heart block	Cardiac disorders	—

Data from ClinicalTrials.gov NCT04350008 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.