This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Model 20105 Lead Study (NCT02301429), a na na study. The primary outcome is All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02301429 |
| Phase | NA |
| Condition | Sick Sinus Node Syndrome |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medtronic BRC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with Sick Sinus Node Syndrome. The primary outcome population was described as all subjects who underwent a Model 20105 Lead implant attempt. The registry record lists an enrollment of 16, but does not report how many enrolled participants underwent an implant attempt or how many contributed to the primary outcome.
Intervention
The intervention was the Model 20105 device lead. The arm description says participants received the Model 20105 Lead. The study purpose was to evaluate the implant procedure and the feasibility of a new lead developed to pace and sense the left chambers of the heart.
Comparator
No comparator arm is listed. The study is recorded as single-group, with allocation marked NA. The registry record therefore does not support a like-for-like treatment comparison or a randomized estimate of effect against another device or procedure.
Primary question
The primary outcome concerned the number of implant-procedure and lead-related adverse events collected during the first month after implant. The central descriptive question is what adverse-event experience was recorded for the Model 20105 group over that timeframe. The record does not provide an analysis comparing the observed count with a prespecified benchmark.
3. Trial Design
The Model 20105 Lead Study is recorded as a single-group device study. Its listed intervention was the Model 20105 lead, and the arm description states that participants received that lead. Allocation is marked NA, and masking is recorded as none. There is no listed control arm, so the design does not provide a randomized comparison with another device, procedure, or usual care.
The registry record lists Sick Sinus Node Syndrome as the condition and an enrollment of 16. The study purpose was to evaluate the implant procedure and feasibility of a lead developed to pace and sense the left chambers of the heart. The study phase is recorded as NA. The listed sponsor is Medtronic BRC.
The recorded start is 2014-11, and primary completion is 2016-07. The current status in the record is terminated. The reason for termination and any consequences for the planned enrollment or follow-up are not reported in the registry record. The record also does not state whether the study stopped before reaching its enrollment target, or whether any formal stopping rule was used.
One primary outcome measure is listed. Its timeframe is 1 month, and the outcome is a count of implant-procedure and lead-related adverse events. The record identifies the analysis population as subjects who underwent an implant attempt; it does not establish that every enrolled participant underwent that attempt. The registry record lists no analysis entries, so the design description should not be mistaken for a detailed statistical analysis plan.
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
| Stage | Model 20105 |
|---|---|
| STARTED | 16 |
| COMPLETED | 13 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Model 20105 |
|---|---|
| not acceptable vascular anatomy | 3 |
Analysis population for the primary outcome, as defined in the registry: all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis
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.
| Characteristic | Unit | Model 20105 |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | years | 73.2 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 8 |
| QRS duration | msec | 108.7 (SD 17.6) |
6. Primary Endpoint
The registry lists the primary outcome as All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed., measured over 1 month.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Adverse Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of adverse events related to the implant procedure and the lead during the first month after implant. The registry specifies a count as the measure and identifies the intended population as all subjects who underwent a Model 20105 Lead implant attempt. It does not define a rate, a time-to-event outcome, or a comparison with another group.
As a general rationale, collecting procedure- and device-related events can describe what complications were observed during an early feasibility study. Counts can help characterize the event burden, while event descriptions can indicate the kinds of issues recorded. That information is descriptive: without a comparator or a stated benchmark, the count alone cannot establish whether the event experience is higher or lower than it would be with another approach.
The registry outcome title says that events will be collected and analyzed, but the record does not report a statistical analysis method for this endpoint. It also does not report an endpoint definition covering how events were judged to be related to the procedure or lead, how recurrent events were handled, or how incomplete follow-up was treated. Those details matter when interpreting a count, because the number can depend on which events qualify and on the completeness of event ascertainment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports adverse-event figures for the Model 20105 group, including 3 serious adverse events among 13 at risk and 3 other adverse events among 13 at risk. The registry also lists three serious-event terms, each with a recorded value of 7.7%: Coronary Sinus Dissection, Iatrogenic pneumothorax, and Coronary Artery Stent Insertion. These entries describe the safety information recorded for this group; they do not constitute a comparison with another treatment.
The figures should be read in the context of the study’s single-group design and its stated one-month endpoint timeframe. The registry does not report a control group, an adjusted analysis, an uncertainty interval, or a hypothesis test for the primary outcome. Consequently, the posted figures do not quantify how the event experience differs from another device or from a counterfactual outcome. They also do not establish the cause of each event beyond the registry’s grouping and terminology.
The registry enrollment is 16, whereas the serious- and other-event summaries each list 13 at risk. The primary outcome population is described as those who underwent an implant attempt, but the record does not state how the listed at-risk population relates to enrollment or give a participant flow explaining exclusions or follow-up. The event summaries should therefore be interpreted using their own stated at-risk counts, rather than assuming that enrollment is the denominator for every outcome.
The three serious-event terms each have the same listed percentage. The record does not explain whether event terms can overlap within a participant, whether repeated events are represented, or whether the percentages refer to participants or event entries. They should not be added together to construct a total. The registry record also does not report a statistical analysis entry, so there is no posted inferential result from which to assess precision or evidence against a null hypothesis.
The study status is terminated, but no reason is reported. Termination alone does not explain whether enrollment, follow-up, or outcome collection was complete. The most defensible reading is therefore limited: the record describes a small, single-group device study and records the adverse-event information stated above, while leaving important details of ascertainment, completeness, and analysis unavailable.
9. Statistical Methods Explained
What does a count endpoint represent?
A count records how many qualifying events are observed within a defined group and timeframe. Here, the endpoint concerns implant-procedure and lead-related adverse events during the first month after implant. A count is not automatically the same as a count of participants: one participant could, in principle, experience more than one event, depending on the endpoint rules. The registry does not report whether recurrent events were counted separately or how the event-counting rules were applied.
As a general statistical point, counts are often interpreted in light of the amount of exposure or observation. A group observed for different lengths of time, or with different completeness of follow-up, may have different opportunities for events to be recorded. This endpoint specifies a one-month timeframe, but the registry does not report the completeness of follow-up or a method for handling participants without complete observation. It also does not report an event rate adjusted for exposure time.
Why does the single-group design matter?
A single-group study can describe events among people receiving the study device, but it does not by itself separate device-related experience from background risk, procedural factors, or other influences. A control group can support a comparative estimate when the groups are suitably assembled and analyzed. No control group is listed for this study, and allocation is recorded as NA. As a result, a comparative treatment effect cannot be recovered from the posted event summaries.
Masking is recorded as none. In general, awareness of the intervention can influence how events are reported, assessed, or attributed, although the record does not establish that any such influence occurred in this study. The registry does not describe blinded event adjudication or independent review. Those details would help readers understand how consistently adverse events were identified and classified.
What can statistical uncertainty tell a reader?
In general, a confidence interval describes the range of values reasonably compatible with observed data under a specified statistical model. For an event count or rate, an interval can convey that estimates based on limited information may be imprecise. The registry record does not provide a confidence interval or another uncertainty measure for the primary outcome. No inferential analysis is listed, so the numerical event summaries should not be presented as precise estimates of the underlying risk.
General count-data methods may use distributional assumptions. A simple model can be inadequate when counts vary more than the model expects, a feature often called over-dispersion. If over-dispersion is present, standard errors and confidence intervals from an unsuitable model can be misleading. The registry does not report a count model, a dispersion assessment, or a method for estimating uncertainty. There is therefore no basis in the record to say whether over-dispersion was assessed or whether it affected any analysis.
What do the planning illustrations mean?
General sample-size illustrations translate an assumed effect and analysis approach into a planning quantity. Their values depend on assumptions, including the effect considered meaningful, the allocation, the significance level, and the statistical method. The record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a stated fraction of the observed effect. These are planning assumptions, not evidence that the actual study had two arms; the recorded trial is single-group.
Any sample-size illustration based on an observed effect is hypothetical planning, not observed power and not a post hoc demonstration that the study could reliably detect an effect. Such calculations do not resolve the limitations of a small, single-group study or supply a comparison that the design did not include. The registry does not report that these assumptions were the trial’s original design rationale or that the sponsor used them to plan the study.
More broadly, a statistical method is interpretable only when its target, population, outcome rules, and assumptions are clear. The registry identifies the endpoint and a population description, but does not report an analysis method, missing-data approach, or detailed analysis population flow. Thus, the posted figures support descriptive reading, while more complex claims about effect, precision, or model-based inference are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no analysis entries. It does not report a multiplicity adjustment or a plan for controlling the chance of false-positive findings across multiple tests. With no posted hypothesis tests, the record does not support a conclusion about whether multiplicity was formally addressed.
The event information includes serious and other adverse-event summaries, along with individual serious-event terms. These categories are useful descriptively, but the record does not say whether they were prespecified as separate statistical comparisons or whether any formal testing was conducted across event types. The terms should not be treated as independent tests or combined into a single inferential claim.
The primary outcome population is described as all subjects who underwent an implant attempt. The record does not report the number of enrolled participants who underwent the attempt, the reasons any participant might have been excluded from this population, or how missing outcome information was handled. It does not describe a missing-data method, imputation, sensitivity analysis, or complete-case rule. No conclusion about missingness or completeness can be drawn from the absence of those details.
In general, an analysis population definition and a missing-data strategy help show who contributed information and how incomplete records may affect conclusions. Those details are especially relevant when a study is terminated, since termination does not itself show whether endpoint collection was complete. The registry does not report whether follow-up was complete for the stated timeframe, or whether outcome ascertainment differed across participants.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Model 20105 | 3 | 13 | 23.1% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Model 20105 | 3 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Model 20105 |
|---|---|---|
| Coronary Sinus Dissection | Injury, poisoning and procedural complications | 1 of 13 |
| Iatrogenic pneumothorax | Injury, poisoning and procedural complications | 1 of 13 |
| Coronary Artery Stent Insertion | Surgical and medical procedures | 1 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Model 20105 |
|---|---|---|
| Coronary Sinus Dissection | Injury, poisoning and procedural complications | 1 of 13 |
| Atrioventricular nodal reentrant tachycardia | Cardiac disorders | 1 of 13 |
| Angina Pectoris | Cardiac disorders | 1 of 13 |
Serious events with the highest arm-level rate: coronary sinus dissection (7.7%), iatrogenic pneumothorax (7.7%), coronary artery stent insertion (7.7%).
The serious-adverse-event summary lists 3 affected among 13 at risk for the Model 20105 group. The other-adverse-event summary also lists 3 affected among 13 at risk. These are separate registry summaries; the record does not clarify whether the categories overlap, how recurrent events were handled, or whether the counts refer to participants or event occurrences. They should not be added together.
The registry lists Coronary Sinus Dissection, Iatrogenic pneumothorax, and Coronary Artery Stent Insertion as the top serious-event terms, each recorded as 7.7%. The record does not explain whether a participant could contribute to more than one term, or provide enough detail to interpret these percentages as mutually exclusive categories. They should be read as separate listed terms, not as components of a total.
Deaths are not reported in the registry record. This is not equivalent to a report that no deaths occurred. The registry also does not provide event narratives, severity criteria, adjudication procedures, or a detailed account of attribution to the device or procedure. Accordingly, these figures describe the entries in the safety record but do not establish causality or comparative safety.
12. What the Result Does, and Does Not, Mean
The result is a descriptive account of adverse events recorded for a single group receiving the Model 20105 lead. The registry identifies an early post-implant timeframe and reports serious and other adverse-event summaries, as well as serious-event terms. This information contributes to the stated feasibility focus by documenting the event experience recorded during the study.
It does not show whether the lead is safer or less safe than another device or procedure, because no comparator group is listed. It does not establish that the lead caused each event, nor does it estimate what would have happened to the same participants under another approach. A single-group event count cannot isolate the influence of the device from procedural context or other factors.
The record also does not support a precise estimate of underlying event risk. It provides no uncertainty interval, analysis method, or detailed account of follow-up completeness. The listed percentages are descriptions attached to individual event terms; they should not be summed or treated as a comprehensive measure of overall risk. The registry does not report a benchmark against which to judge the observed event count.
The enrollment entry and at-risk summaries refer to different recorded quantities, and the registry does not provide a participant flow reconciling them. The outcome population is described in terms of implant attempts, but the record does not report how many participants underwent an attempt. The terminated status provides no explanation of why the study ended or whether all planned data collection was completed.
In short, the record documents what adverse-event information was listed for this device study, but leaves key questions about event definitions, completeness, and analysis unanswered. It is not a comparative efficacy result or a definitive estimate of safety.
13. Why This Trial Matters Statistically
This study illustrates how registry outcome summaries need to be read alongside design information. A count of adverse events can be informative as a description of what was recorded, but its interpretation depends on the population, timeframe, event definition, and completeness of observation. The record identifies some of those elements, while leaving others unreported.
The study is single-group, with no listed comparator and no allocation to competing interventions. That distinction is important: event counts in a device feasibility study can document experience, but they cannot establish a comparative treatment effect. Likewise, an event term or percentage does not by itself establish causation.
The difference between enrollment and the at-risk population listed in the event summaries also highlights why participant flow matters. Without an account of who underwent an implant attempt and who contributed follow-up, readers cannot determine from the registry alone how the outcome population relates to enrollment. Such reporting is central to interpreting denominators and assessing completeness.
Finally, the absence of a listed analysis method or uncertainty measure limits claims about precision. General statistical methods can quantify uncertainty, but their interpretation depends on stated assumptions and transparent outcome handling. This record is therefore useful as an example of why descriptive safety figures, study design, analysis reporting, and missing-data information must be considered together.
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 record does not report why the study was terminated, whether the planned enrollment was reached, or whether all intended follow-up was completed. The listed enrollment is 16, but the primary outcome population is defined by implant attempt, and the number undergoing an attempt is not reported. The event summaries list 13 at risk, without a participant flow explaining how that population relates to enrollment.
Event definitions and ascertainment procedures are not described in detail. The registry does not explain how events were attributed to the implant procedure or lead, whether event terms could overlap, how repeated events were treated, or how seriousness was determined. These omissions restrict interpretation of the event categories and their percentages.
No control group is listed, and masking is recorded as none. The record does not report blinded or independent event review. The design therefore cannot provide a randomized comparison, and potential differences in event reporting or classification cannot be assessed from the registry information.
The registry lists no analysis entries and does not report uncertainty intervals, a missing-data method, or a detailed statistical plan. It also does not report a reason for termination or whether adverse-event follow-up was complete. Deaths are not reported in the registry record. These gaps mean the posted figures should be treated as descriptive entries rather than as a complete, comparative safety assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Model 20105 Lead Study — NCT02301429.
- Registry record last updated 2016-10-26; status last verified 2016-09.
- Results first posted 2016-10-26.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The Model 20105 Lead Study is a terminated, single-group device study sponsored by Medtronic BRC. The registry lists Sick Sinus Node Syndrome as the condition, an enrollment of 16, and the Model 20105 lead as the intervention. Allocation is marked NA and masking is recorded as none.
The stated purpose was to evaluate the implant procedure and feasibility of a lead developed to pace and sense the left chambers of the heart. The primary outcome is a count of implant-procedure and lead-related adverse events during the first month after implant, among subjects who underwent an implant attempt.
The safety record lists 3 serious adverse events among 13 at risk and 3 other adverse events among 13 at risk. Three serious-event terms are each listed as 7.7%. The registry record lists no analysis entries. It does not report the termination reason, a comparator, uncertainty estimates, or details of missing outcome information.