Electronic Device Implantation Through Remote Guidance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Electronic Device Implantation Through Remote Guidance (NCT06404021), a randomized na study. The primary outcome is Percentage of Participants With Interventional Procedures Successfully Completed.

2. Clinical Question

The clinical question is whether interventional cardiology procedures supported by an engineer remotely can be completed as recorded in the registry, compared with procedures supported by an engineer in the electrophysiology laboratory. The record describes a remote proctoring system and defines a procedure as complete and feasible when implanted-lead electronic measurements are optimal, including effective pacing at the specified threshold.

The endpoint timeframe runs from enrollment to the end of treatment at 12 months. The registry gives counts of participants with successful completion in the remote-support group and the in-laboratory group. Those counts describe the recorded outcomes in this trial; they do not, on their own, establish how well remote support would perform in other settings or with other teams and procedures.

3. Trial Design

The registry identifies this as a randomized, open-label, single-center trial. Allocation is recorded as randomized, masking as none, and the study model as factorial. The record does not describe the randomization sequence, allocation concealment, the factorial factors, or how the factorial designation relates to the two support approaches described in the arms. Those design details are not reported in the registry record.

The study is marked completed and lists enrollment of 30. The recorded arms are procedures with an engineer in remote support, with 10 participants, and procedures with an engineer in the electrophysiology laboratory, with 20 participants. The listed sponsor is the University of Calabria. The record gives a start date of 2022-06-01 and a primary completion date of 2023-09-30.

The study summary describes an initial programming and phantom-assessment phase involving 20 cases, followed by 10 remote-guided CRT-D and ICD implantations in additional heart failure patients, compared with 20 procedures with an FCS on site. The arm records list the participant counts used for the primary outcome. The registry does not explain how the phantom work relates to the randomized participant groups or whether it was part of the listed enrollment.

The record classifies the study phase as NA. It does not report the trial protocol, sample-size justification, details of the allocation process, or an analysis plan. Thus, the design can be described from the registry classifications and arm records, but important operational and statistical details cannot be reconstructed from this record alone.

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

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.

Population: both genders and in range 18 ÷ 85 years of age

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Interventional Procedures Successfully Completed, measured over From enrollment to the end of treatment at 12 months.

The primary endpoint is titled Percentage of Participants With Interventional Procedures Successfully Completed. Its recorded unit and parameter describe a count of participants, rather than a percentage value. The remote-support arm has 10 participants recorded as successful, out of 10; the in-laboratory arm has 20 recorded as successful, out of 20.

The endpoint description defines completion and feasibility by the electronic measurements of all implanted leads being optimal, particularly effective pacing at a threshold less than 1 Volt @ 0.5 millisecond. It frames the measure as a way to assess whether procedures using the proctoring system can reach the specified technical completion criterion compared with operations supported on site. The timeframe is from enrollment to the end of treatment at 12 months.

This kind of endpoint addresses whether the procedure meets a prespecified technical condition, rather than measuring a broader clinical outcome. The registry does not provide a more detailed account of how measurements were assessed, who adjudicated completion, or how a case with incomplete or unavailable measurements would be classified. Those details are not reported in the registry record.

7. Results Posted in the Registry

• Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory: 100.0% (20/20) versus 100.0% (10/10) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a binary participant-level result: a participant either has a procedure recorded as successfully completed under the endpoint definition or does not. For a binary outcome, the basic summary is the number meeting the criterion and the number assessed in each group. The registry lists 10 successful participants among 10 in remote support and 20 among 20 in the electrophysiology laboratory group. The recorded group proportions are 1.0 for both arms.

What does the risk difference describe?

A risk difference subtracts the outcome proportion in one group from the outcome proportion in the other, with the direction depending on which group is treated as the reference. It is expressed on the proportion scale. The posted risk difference is 0.0, and its reported interval runs from 0.0 to 0.0. This says that the point estimates in the registry are identical. It does not by itself establish that the groups have the same underlying probability of completion.

What does the risk ratio describe?

A risk ratio divides one group's outcome proportion by the other's. A value of 1.0 means the two observed proportions are equal. Here, the record reports a risk ratio of 1.0 and an interval from 1.0 to 1.0. Because both observed proportions are at the maximum, the ratio is based on two groups with no recorded failures. The record does not identify the interval method or explain how uncertainty was handled for these boundary results.

Why do counts and denominators matter?

The count and denominator show how much information underlies each proportion. A proportion alone can conceal whether it comes from a small or large group. In this trial, the remote group has 10 participants and the in-laboratory group has 20. Both groups have all recorded participants meeting the endpoint, but the group sizes differ. Equal observed proportions do not mean equal precision: estimates from groups with fewer observations are generally less stable, and an absence of observed failures does not rule out a nonzero failure probability in a wider population.

What can confidence intervals contribute?

In general, a confidence interval is a range calculated by a statistical procedure to represent uncertainty around an estimate. Its interpretation depends on the estimator, assumptions, and interval method. A useful interval should reflect the uncertainty in the data and method, rather than simply repeat a point estimate. The registry reports zero-width intervals for the risk difference and risk ratio here, but does not report the procedure used to produce them. Readers therefore cannot determine from the record whether the intervals account appropriately for the small group sizes and all-success outcome pattern.

What does randomization contribute?

In general, random allocation is intended to make assigned groups comparable on average with respect to measured and unmeasured factors, subject to how allocation was implemented and whether participants were analyzed as assigned. The registry labels allocation randomized, but does not report the sequence-generation method, concealment, adherence, crossovers, or analysis population. The label alone cannot answer those questions. The study is also described as open-label, so masking is recorded as none. The record does not explain whether outcome assessment was independent of support assignment.

How should the planning illustrations be read?

Any sample-size figures associated with planning are illustrations based on the observed effect, not a description of the trial's original design or observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. These are planning assumptions, not observed outcomes. The registry record does not provide the trial's own sample-size justification, and such illustrations cannot substitute for an uncertainty analysis of the actual trial results.

Over-dispersion is a general concern when outcomes vary more than a chosen statistical model expects; it can make uncertainty estimates too narrow if the model fails to account for that extra variation. For this primary endpoint, all recorded outcomes are successes, so the posted results do not show within-arm outcome variation with which to assess that issue. No fitted model, variance adjustment, or other inferential analysis is reported in the registry record. The comparison should therefore be read as a descriptive summary with a posted effect estimate, not as a fully documented model-based analysis.

10. Confidence Intervals and Precision

The precision information posted for the primary comparison consists of a risk difference of 0.0 with confidence limits of 0.0 and 0.0, and a risk ratio of 1.0 with limits of 1.0 and 1.0. Both arm proportions are reported as 1.0. These intervals have no visible width in the recorded values. Since values in the record are rounded, the display communicates only what is posted; it cannot reveal whether any unrounded calculation differed.

In general, a confidence interval is meant to express uncertainty around an estimate under a specified method. Its width depends on the data and the method, and its meaning depends on the assumptions used to calculate it. The registry record does not identify the interval procedure, state whether it is an exact or approximate method, or provide additional inferential details. The intervals therefore cannot be independently interpreted as a complete account of sampling uncertainty from the registry information alone.

All participants in both groups are recorded as meeting the primary criterion. When no failures are observed, the data do not show how the failure probability would behave in future cases. A point estimate at the boundary should not be mistaken for certainty that the underlying probability is exactly at that boundary. The listed group sizes also matter: estimates based on the remote arm's 10 participants cannot be assumed to have the same precision as estimates based on the in-laboratory arm's 20 participants.

The posted intervals should be read alongside the counts, endpoint definition, and missing statistical-method details. They document the registry's reported comparison, but the record does not provide enough information to assess whether their zero width is an appropriate representation of uncertainty. No alternative recalculation is needed to state this limitation.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and no posted secondary outcomes. It also lists no analysis entries. The primary comparison is nevertheless posted as a result. The record does not describe a prespecified hierarchy of outcomes, an adjustment for multiple testing, or which outcomes were designated primary at each stage. A multiplicity strategy is therefore not reported in the registry record.

Multiplicity matters in general when several outcomes, time points, groups, or analyses are examined: the chance of finding an apparently notable result can depend on how many comparisons are made and how they are selected. The record does not provide enough detail to determine which comparisons were conducted beyond the posted primary comparison. The summary refers to acute outcomes and electronic parameters at one-year follow-up, but does not list their numerical results or analysis procedures.

The analysis population is not described. The registry does not say whether the primary result uses an intention-to-treat population, a per-protocol population, or another definition. It also does not report participant flow, exclusions after randomization, protocol deviations, or whether participants remained in their assigned groups for analysis. Although the arm records give outcome counts and denominators, those entries do not answer all population-definition questions.

Missing-data handling is also not reported. The record does not state whether any endpoint measurements were unavailable, how incomplete procedures were classified, or what methods were used if follow-up or electronic measurements were missing. The recorded counts show successful outcomes for the listed participants, but should not be taken as a full account of missingness or exclusions without that information.

These omissions limit assessment of selective reporting and analysis robustness. They do not establish that missing data or multiplicity problems occurred; they mean the registry record does not document how those issues were addressed.

12. 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.

The adverse-event records list zero serious adverse events among 10 participants at risk in the remote-support group and zero among 20 at risk in the in-laboratory group. They also list zero other adverse events in each group and zero deaths in each group. No serious adverse-event terms are listed.

These are event counts as recorded in the registry. They do not establish that no adverse events of any kind occurred outside the registry's reporting definitions or observation procedures. The record does not provide the adverse-event definitions, collection methods, attribution rules, or a separate adverse-event follow-up window. The primary endpoint timeframe is from enrollment to the end of treatment at 12 months, but the registry does not explicitly state that the adverse-event records use the same timeframe.

With no serious events recorded in either group, the observed data do not support a comparison of the frequency or type of serious events between support approaches. In general, the absence of observed events in a trial does not rule out events in a larger population or under different circumstances. The safety figures should be read as the registry's reported counts, not as proof of no risk or as a complete safety assessment.

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

The primary result is straightforward at the level of the recorded endpoint: all participants listed in each arm had a procedure recorded as successfully completed under the registry definition. The comparison reports a risk difference of 0.0 and a risk ratio of 1.0. The outcome is completion against a technical criterion for lead measurements and pacing, with follow-up described through the end of treatment at 12 months.

This result does not establish that remote support and in-laboratory support are equivalent. Equivalence requires a prespecified margin and an analysis designed to assess whether the difference lies within that margin; neither is reported in the registry record. It also does not establish non-inferiority, because no non-inferiority margin or corresponding analysis is provided. Identical observed proportions are not a substitute for those designs.

The findings do not show that the approaches have identical performance in all hospitals, with all operators, or across all types of procedures. The trial is identified as single-center, and the record does not describe the full range of staff, equipment, or clinical circumstances. Its primary result concerns the participants and procedures represented in this registry entry.

The study summary makes broader statements about acute outcomes, electronic parameters at one-year follow-up, and safety after testing at one year. The registry record does not include the numerical secondary results or analysis details needed to assess those statements independently. The primary completion outcome should not be used as a substitute for those unposted results.

Finally, the result is not evidence that every attempted procedure will be completed successfully in future practice. The record gives no observed failures, but the groups are limited in size and the posted interval method is not specified. The defensible interpretation is that successful completion was recorded for all listed participants in each arm, while the precision and generalizability of that observation remain uncertain from the registry information.

14. Why This Trial Matters Statistically

This trial is statistically interesting because its primary outcome is a practical technical completion criterion, and the observed data are at the ceiling in both groups. Ceiling results can create an appealingly simple comparison: each arm has the same recorded proportion and the risk difference is 0.0. They also create an important interpretive challenge, because there are no observed failures to show how the outcome might vary across participants or settings.

The record makes clear why estimates should be read together with their counts and methods. A proportion of 1.0 in each group may look definitive, but the remote-support result is based on 10 participants and the in-laboratory result on 20. The posted confidence intervals have zero width, yet the registry does not document how they were calculated. The contrast between a boundary estimate and a zero-width interval is a reason to seek methodological detail, not a reason to assume certainty.

The randomized label is relevant to the comparison, but the record provides little information about how randomization was implemented or how participants were handled after assignment. Likewise, the factorial designation is not explained in relation to the listed support groups. These omissions matter because design labels alone do not show how a comparison was conducted or analyzed.

Finally, the registry distinguishes a primary completion outcome from broader claims in the study summary. That distinction is important for transparent interpretation: a posted primary result can be described precisely, while unposted secondary estimates cannot be evaluated from this record. The trial therefore illustrates how clear counts can coexist with substantial uncertainty about interval methods, analysis populations, and the scope of conclusions.

15. 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 registry record does not fully define the enrolled population. It refers to additional heart failure patients in the summary and identifies ICD and CRT-D procedures, but does not provide detailed eligibility criteria, baseline characteristics, or participant flow. The relationship between the programming and phantom-assessment phase and the randomized participant groups is also unclear from the record.

Although the trial is described as randomized, the method of sequence generation and allocation concealment is not reported. The study is open-label, with no masking recorded, and the record does not say whether outcome measurement or adjudication was independent of support assignment. The factorial model designation is present, but its factors and analytic implications are not described.

The primary endpoint is a count under a technical definition, while its title refers to a percentage. The record does not explain the discrepancy between that title and the count parameter, or describe procedures for unavailable measurements and incomplete cases. It also does not provide a statistical plan, sample-size justification, or interval method. These details are particularly relevant because both groups have all-success results and the reported confidence intervals have zero width.

Finally, no secondary outcomes are posted despite the summary's statements about acute outcomes and one-year electronic parameters. Adverse-event definitions and their observation period are not reported. Together, these gaps constrain evaluation of the broader safety and outcome claims and limit how confidently the primary result can be generalized beyond the listed participants and procedures.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Electronic Device Implantation Through Remote Guidance — NCT06404021.
• Registry record last updated 2025-07-20; status last verified 2025-07.
• Results first posted 2025-07-20.
• 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.

19. Record Summary

The registry describes a completed, randomized, open-label, single-center study sponsored by the University of Calabria. It compares interventional cardiology procedures with an engineer in remote support against procedures with an engineer in the electrophysiology laboratory. Enrollment is listed as 30, and the record identifies the study model as factorial without describing its factors.

The primary endpoint is successful procedure completion, defined using optimal electronic measurements of implanted leads and effective pacing. The remote-support arm records 10 successful participants among 10; the in-laboratory arm records 20 among 20. The posted risk difference is 0.0, and the risk ratio is 1.0, with zero-width confidence intervals as recorded.

No secondary outcomes are posted, and the registry does not describe the interval method, analysis population, missing-data handling, or multiplicity approach. The adverse-event records list zero serious events, zero other events, and zero deaths in each group. These findings describe the registry entries and do not resolve the unreported methodological details or establish equivalence between the support approaches.