Medical Devices
Conditions
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.
Interventions
DEVICERenamic 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.
Sponsors
Biotronik Australia Pty Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implantation and Follow-up Use Cases Implantation use cases including PSA measurements. Pre-hospital discharges of these patients account for follow-up use cases. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Implantation and Follow-up Use Cases | — |
|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 13.2 | — |
| Height [cm] | 171.4 cm STANDARD_DEVIATION 10.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 110 participants | — |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 68 Participants | — |
| Weight [kg] | 84.5 kg STANDARD_DEVIATION 19.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 1 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
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.
Time frame: 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).
Population: Analysed were 49 implantation use cases and 102 follow-up use cases which include interrogations at pre-hospital discharge. Analysed were all implantation, pre-hospital discharge and follow-up cases for which the Renamic Neo programmer was used.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Implantation and Follow-up Use Cases | Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases | 0 use cases for Renamic Neo |