BIO|CONCEPT.Renamic Neo Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for BIO|CONCEPT.Renamic Neo Study (NCT04350008), a registered phase not stated study. The primary outcome is Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases.

2. Clinical Question

In practical terms, the study was designed to collect reports arising while the programmer was used for implantation and follow-up activities. Investigators were asked to report adverse device effects and device deficiencies. Collection was specified for all adverse device effects related to the investigational device and for device deficiencies considered to have the potential for a medical occurrence.

The registry outcome is organized around counts and use-case denominators, rather than a treatment-versus-control contrast. It is therefore a descriptive safety and device-performance question: what device effects or qualifying deficiencies were reported in the stated use settings, relative to the number of relevant uses? The registry record does not give the primary endpoint count, so that question cannot be answered numerically from the posted primary outcome information.

3. Trial Design

BIO|CONCEPT.Renamic Neo, also identified as NCT04350008, is described as a pre-market study of the Renamic Neo programmer system. The study status is completed. Its recorded start date is 2020-06-08, and its primary completion date is 2020-10-29. Enrollment is recorded as 110. The sponsor is Biotronik Australia Pty Ltd.

The listed device intervention comprises the Renamic Neo programmer device, including software, and the PK-222-L ECG cable. The stated purpose was to provide clinical data and supporting evidence about the system's safety, performance and usability. These are aims described in the registry summary; they should not be mistaken for numerical findings.

The record does not state allocation, a randomized design, or a control intervention. It does not describe a comparison between arms. The device group in the adverse-event information is titled Implantation and Follow-up Use Cases, but the existence of that group does not establish that a separate comparator was used. The record also does not explain whether each use case represents a different participant or whether a participant could contribute more than one use case.

For the primary outcome, the record says that 49 implantation use cases and 102 follow-up use cases were analyzed. Follow-up use cases include interrogations at pre-hospital discharge, and all implantation, pre-hospital discharge and follow-up cases for which the programmer was used were analyzed. The reported observation timeframe describes participation from implantation until pre-hospital discharge, usually 1-2 days, or participation only for an in-office follow-up, usually 1 day.

Other design details, including the study protocol, eligibility criteria, recruitment procedures, masking, and the planned statistical analysis, are not reported in the registry record. The record's completed status indicates the listed study status, not that every planned outcome is numerically available in the posted results.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 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.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases, measured over 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 primary endpoint is the number of adverse device effects and device deficiencies per number of Renamic Neo use cases. It distinguishes implantation use cases from pre-hospital discharge and follow-up cases. The outcome is classified as a count, not as a continuous measurement or a time-to-event endpoint.

The endpoint was intended to capture events during use of the programmer at implantation, pre-hospital discharge and on-site follow-up. Investigators were asked to report any adverse device effects or device deficiencies occurring during those activities. The registry specifies collection of all adverse device effects related to the investigational device, but only device deficiencies judged to have the potential for a medical occurrence. This distinction matters: the endpoint description does not say that every technical deficiency, regardless of potential, was collected.

Using use cases as denominators makes the outcome relevant to the occasions on which the device was used. It also means that the denominator is not automatically interchangeable with the number of enrolled participants. The registry reports 49 implantation use cases and 102 follow-up use cases, but does not explain participant-level overlap between those categories.

General: a count endpoint describes how many qualifying events were observed, while a denominator gives context about the amount of use or observation. For an event-per-use interpretation, both the event definition and the denominator must be clear. The primary endpoint's numerical count and any resulting rate are not reported in the registry record, so its magnitude cannot be assessed from the endpoint description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count outcome. It concerns adverse device effects and selected device deficiencies associated with use of the Renamic Neo programmer. The record organizes the count by implantation use cases and pre-hospital discharge or follow-up use cases. It specifies that all device-related adverse effects were to be collected, while device deficiencies were collected only if judged to have potential for a medical occurrence.

What does a count endpoint tell us?

A count records the number of events meeting a definition. It does not, on its own, show how frequently an event occurs unless the relevant denominator is also considered. In this study, the endpoint description identifies use cases as the denominator context. The registry gives 49 implantation use cases and 102 follow-up use cases, including pre-hospital discharge interrogations. It does not report the primary event counts for these categories, so neither a count-per-use summary nor a comparison across settings can be read from the primary outcome record.

General: if events are uncommon, counts can be highly dependent on the amount of observation and the completeness of event reporting. A count over more uses may be larger simply because there were more opportunities to observe an event. Comparing counts without considering denominators can therefore be misleading. Conversely, a denominator alone does not identify the event frequency; the event definition and the event count are also required.

Why do denominators and units matter?

The outcome unit is stated as use cases for Renamic Neo. The record separately reports enrollment of 110, 49 implantation use cases and 102 follow-up use cases. These quantities should not be treated as interchangeable. One participant may potentially contribute more than one type of use case, but participant-level overlap is not described in the registry record. The safety summary's 110 at-risk entries likewise cannot be assumed to represent the same denominator as either use-case category without an explicit explanation.

General: an analysis can be described at the participant level, the use level or the event level. A participant-level proportion asks how many people had at least one event; an event count can include more than one event per person; a use-level frequency relates events to device-use occasions. Those measures answer different questions. The registry's endpoint is framed around use cases, but the numerical primary results needed to distinguish the event counts from any participant-level summaries are not reported.

What does statistical precision mean?

General: a confidence interval describes a range of values compatible with an estimate under the analysis assumptions. It communicates uncertainty that a point estimate alone cannot show. For count outcomes, uncertainty depends on the count model, the number of observations or uses, and the way repeated observations are handled. No confidence interval or other precision estimate for the primary endpoint is reported in the registry record. The precision of the primary outcome therefore cannot be assessed from the posted results.

General: over-dispersion occurs when counts vary more than a chosen count model expects. If it is present, a model that assumes less variability can produce uncertainty estimates that are too narrow. Whether a count model was used, whether over-dispersion was assessed, and how multiple use cases from the same participant were handled are not reported in the registry record. It would be inappropriate to infer any of those methods from the endpoint's count classification.

How should planning calculations be read?

General: sample-size calculations are planning tools, not findings about the observed data. The planning assumptions recorded for illustrations use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation; they describe the effect to detect as a stated fraction of the observed effect. The assumptions say that non-time-to-event illustrations concern participants per arm, while time-to-event illustrations concern total events. These are planning conventions, not evidence that this study used two arms or that it was designed around those assumptions.

The record does not state a randomized comparison, and the actual study design is not described as a two-arm comparison. The numeric planning outputs are not reported in the registry record. Any sample-size illustration should therefore be treated as hypothetical, not as a trial result or an observed-power calculation. Observed power is not a substitute for an estimate with a confidence interval; the record does not report the primary endpoint estimate or its precision.

Finally, the registry lists no analyses for the outcome. It does not report a statistical model, testing procedure, adjustment strategy or inferential result. General statistical concepts can help explain what such methods would address, but they cannot fill in methods or results that are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record does not report a multiplicity plan. It lists one primary outcome measure, but does not describe whether additional outcomes or subgroup analyses were planned, how multiple tests would be handled, or whether any hierarchy of outcomes was specified. With no reported inferential analyses, there is also no reported multiplicity adjustment to interpret.

Missing-data methods are not reported in the registry record. The endpoint description says that investigators were asked to report qualifying adverse device effects and deficiencies, but it does not state how incomplete follow-up, missing reports or uncertain event classifications were handled. The record does not describe monitoring for completeness of reporting or any imputation approach. A request to report events should not be taken as proof that reporting was complete.

The stated analysis population consists of all implantation, pre-hospital discharge and follow-up cases for which Renamic Neo was used. The record gives 49 implantation use cases and 102 follow-up use cases, including interrogations at pre-hospital discharge. It does not explain exclusions, whether all enrolled participants contributed use cases, or how repeated use cases from the same participant were treated. The relation between these use cases and the enrollment of 110 is not reported in the registry record.

General: multiplicity concerns the chance of false-positive findings when several statistical questions are tested; missing-data methods address how unavailable information affects estimates. Those issues are relevant to interpretation, but no specific procedure can be attributed to this study from the record. The absence of a reported method is not evidence that a particular method was or was not used outside the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event summary lists 0 serious events among 110 at risk, 1 other event among 110 at risk, and 0 deaths. The group is titled Implantation and Follow-up Use Cases. These figures should be read as the safety counts recorded in the registry, not as the primary endpoint results for adverse device effects and device deficiencies.

The record does not name the one other event in the available information, nor does it state that the event met the primary endpoint definition. It also does not explain how the 110 at-risk denominator relates to the 49 implantation use cases and 102 follow-up use cases. These distinctions limit what can be inferred from the counts.

General: an observed count is not a guarantee about the range of outcomes that could occur in other settings or with further observation. The interpretation of safety counts depends on event definitions, duration of observation, completeness of reporting, and the denominator. The registry describes participation from implantation until pre-hospital discharge, usually 1-2 days, or participation only for an in-office follow-up, usually 1 day. That timeframe is relevant context, but it does not establish how fully events were captured.

The figures are descriptive. No comparator or inferential safety analysis is reported, and the record does not provide a confidence interval for these counts. They should not be used to make a comparative claim or to substitute for the missing numerical primary endpoint result.

12. What the Result Does, and Does Not, Mean

The record establishes that BIO|CONCEPT.Renamic Neo was completed as a pre-market study and describes a planned focus on device safety, performance and usability. It identifies the intervention, the settings in which use cases were analyzed, and the primary outcome's event definitions. It also records 0 serious events, 1 other event and 0 deaths in the adverse-event summary.

Those details do not provide a numerical answer to the primary endpoint question. The primary result is intended to count adverse device effects and qualifying device deficiencies by implantation and follow-up use cases, but those counts are not reported in the registry record. The one other event in the adverse-event summary cannot be assigned to that endpoint based on the available description.

The record also does not report a comparison group, a comparative effect estimate, a confidence interval or a hypothesis test. As a result, it does not establish whether outcomes differ from another device or from another setting. The stated pre-market purpose and completed status do not supply missing outcome data.

General: descriptive counts can characterize what was recorded in a study, while comparative and inferential claims require a defined comparison and suitable analysis. Precision claims require an estimate and an uncertainty measure. Neither a missing endpoint count nor the absence of reported events in one category should be turned into a claim that a device is effective, ineffective, safe or unsafe.

The most defensible reading is therefore bounded: the registry documents the intended safety endpoint and some adverse-event counts, but does not report the main outcome values needed to quantify adverse device effects or deficiencies per use case. Any broader interpretation would go beyond the results recorded.

13. Why This Trial Matters Statistically

This study highlights a basic statistical distinction between an event count, a denominator and an endpoint result. The registry defines an endpoint around adverse device effects and selected device deficiencies per use case, then reports the numbers of implantation and follow-up uses analyzed. Yet without the corresponding primary event counts, the endpoint cannot be quantitatively interpreted. A clearly described denominator cannot replace the outcome numerator.

It also illustrates why units of analysis deserve attention. Enrollment is 110, while the primary outcome description reports 49 implantation use cases and 102 follow-up use cases. Those quantities refer to different concepts in the record. Without information about overlap and repeated use, readers cannot assume that use cases equal participants or that the safety denominator matches either use-case denominator.

The safety summary further demonstrates that related event labels need not be interchangeable. Its count of 1 other event is not identified as an adverse device effect or qualifying device deficiency. Statistical interpretation depends on the prespecified definition and classification, not merely on the presence of a count in a related safety summary.

Finally, a completed pre-market study can have a stated purpose and a defined endpoint while leaving key numerical results or methods unreported. This makes transparent reporting of event counts, denominators, analysis populations and uncertainty especially important. The registry record supports a careful description of what is listed, and it also makes clear where numerical interpretation must stop.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The central limitation is that numerical results for the primary endpoint are not reported in the registry record. Although the endpoint is described in terms of adverse device effects and device deficiencies by use setting, the record does not give those counts. The endpoint's magnitude and distribution across implantation and follow-up therefore cannot be assessed.

The relation among enrollment of 110, 49 implantation use cases, 102 follow-up use cases and the adverse-event denominator of 110 is not explained. The record does not state whether a participant could contribute multiple use cases or both types of use case. This limits interpretation of denominators and any assessment of dependence among observations.

The adverse-event summary gives 0 serious events, 1 other event and 0 deaths, but the other event is not named in the available information. Its relation to the primary endpoint is not reported. The registry also does not provide confidence intervals, statistical tests or a model for the count outcome.

Study design details such as allocation, comparator, eligibility criteria, missing-data procedures, event-reporting completeness and handling of repeated uses are not reported in the registry record. The observation timeframe is described as usually 1-2 days from implantation to pre-hospital discharge, or usually 1 day for in-office follow-up, but the record does not give further detail about individual observation duration. These reporting gaps constrain interpretation; they do not establish that the study lacked procedures beyond those recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: BIO|CONCEPT.Renamic Neo Study — NCT04350008.
• Registry record last updated 2022-09-16; status last verified 2020-05.
• Results first posted 2022-09-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

BIO|CONCEPT.Renamic Neo Study (NCT04350008) is listed as a completed pre-market study sponsored by Biotronik Australia Pty Ltd. The recorded start date is 2020-06-08, the primary completion date is 2020-10-29, and enrollment is 110. The intervention is the Renamic Neo programmer device, including software, and the PK-222-L ECG cable.

The primary outcome concerns adverse device effects and selected device deficiencies per implantation and follow-up use cases. The record describes 49 implantation use cases and 102 follow-up use cases, including pre-hospital discharge interrogations, but does not report numerical primary endpoint results.

The adverse-event summary records 0 serious events, 1 other event and 0 deaths among 110 at risk in each listed event category. The registry record does not identify the other event or connect it to the primary endpoint. Allocation, a comparator, inferential analyses, precision estimates and several analysis details are not reported in the registry record.