A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter (NCT05373862), a na na study. The primary outcome is Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s).

2. Clinical Question

The study’s stated purpose was to assess performance and safety of the investigational catheter for intracardiac mapping in the atria and ventricles. It therefore addresses device use during clinical procedures, rather than a comparison of treatment outcomes between separately assigned groups. The endpoint focuses on whether mapping could be performed using the study catheter without turning to non-study mapping catheters. That is a procedural performance question; it does not, by itself, answer whether the device changes longer-term health outcomes.

The registry lists several arrhythmia conditions and both atrial and ventricular procedures. It does not report condition-specific primary endpoint results or enough outcome detail to determine how results varied across these clinical settings. Consequently, the primary question can be described from the endpoint definition, but the posted record does not establish how often its criterion was met.

3. Trial Design

The registry describes a completed, single-group device study sponsored by Biosense Webster, Inc. Enrollment was 40. The study began on 2022-07-29, and primary completion was recorded as 2023-02-20. Phase and allocation are listed as NA; masking is listed as none. These entries describe a study without a listed randomized allocation or masking scheme. There is no like-for-like control group identified in the record.

Participants with cardiac arrhythmias or an ablation history were scheduled for clinically indicated catheter mapping and ablation procedures. The intervention was the globe-shaped, high-density, multi-electrode mapping catheter. The record describes its use in atrial and ventricular procedures. Since this is a single-group design, the study can report observations during use of the investigational device, but it cannot use a concurrent assigned control group to distinguish the device’s performance from differences between groups.

The primary endpoint concerns participants whose pre-ablation mapping requirements and clinically indicated mapping were completed using the investigational catheter without resort to non-study mapping catheters. Its stated timeframe is up to 7 days of the index procedure on Day 1. The primary analysis population is described as the per-protocol set, including participants who completed the protocol-required pre-ablation mapping with the investigational catheter. The relationship between that population and all enrolled participants is not further quantified in the registry record.

The record lists secondary physician assessments concerning maneuverability and handling, signal collection and quality, pacing, catheter design, workflow, visualization, catheter interactions, and arrhythmogenicity. It records 15 outcome measures and 0 analyses. Specific analytic procedures, endpoint summaries, and statistical results are not reported in the registry record. The study status is completed, but the record’s completion status does not supply the missing efficacy or performance estimate.

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: Per-protocol analysis set included all participants who completed the protocol-required "pre-ablation mapping" with the investigational catheter.

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 Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s), measured over Up to 7 days of index procedure on Day 1.

The primary endpoint counts participants who had pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheters. It is reported as a count of participants, with the timeframe stated as up to 7 days of the index procedure on Day 1. The endpoint is therefore a participant-level procedural measure: it asks whether the specified mapping circumstance was achieved, rather than measuring a continuous quantity such as mapping time or signal amplitude.

This type of endpoint is used to describe whether a device can be used to complete the mapping task defined by the study. The criterion includes both completion of clinically indicated mapping and no resort to non-study mapping catheters. That makes the measure directly relevant to the stated procedural performance objective. It also sets a specific boundary for what counts: use of the investigational catheter alone for the defined mapping requirement, according to the endpoint wording.

In general, a clearly defined procedural endpoint can make the intended performance question easier to interpret than a broad, unspecified measure. Its meaning still depends on how the criterion is applied, how participants who do not meet it are classified, and how incomplete observations are handled. Those details are not reported in the registry record. The registry gives the endpoint description and the per-protocol population definition, but does not report the number of participants meeting the endpoint or an estimate of its uncertainty. As a result, the endpoint’s definition can be explained, but its observed performance result cannot be evaluated from the posted record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design tell readers?

In general, a single-group study describes outcomes observed among participants exposed to the study intervention. It can document whether a prespecified procedural task was completed and describe reported events in that group. Without a concurrent comparison group, however, it cannot directly estimate how outcomes would differ under an alternative device or procedure. Differences between observed experience and a hypothetical alternative cannot be measured from the single group alone.

Here, the record identifies a single-group model, allocation listed as NA, and masking listed as none. It does not list a control arm. The study should therefore be read as a device evaluation with observations in the investigational catheter group, not as a randomized comparative trial. This design description does not determine whether the study was appropriate for its intended question; it defines the kinds of conclusions the recorded design can support.

What kind of endpoint is the primary measure?

The primary outcome is a count of participants meeting a defined procedural criterion. The criterion combines completion of pre-ablation mapping requirements and clinically indicated mapping with use of the investigational catheter without resort to non-study mapping catheters. In general, a participant-level binary endpoint classifies each participant according to whether the criterion was met; a count then reports how many participants fall into the qualifying category. The registry’s outcome type is described as participants with an event, in counts.

A count is easiest to interpret when the analysis denominator and classification rules are also available. The record describes the per-protocol population as participants who completed the protocol-required pre-ablation mapping with the investigational catheter. It does not report the size of that population, the endpoint count, or a detailed rule for handling participants whose mapping was incomplete or whose status was unavailable. Those omissions prevent reconstruction of the result.

What does a confidence interval communicate?

In general, a confidence interval expresses uncertainty around an estimated quantity under a statistical model and its assumptions. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. An interval does not remove the limitations of the study design, and it does not establish that an observed result would apply to populations or procedures not represented in the study. No confidence interval for the primary endpoint is reported in the registry record.

Why are analysis populations important?

In general, different analysis populations can answer different questions. A per-protocol population focuses on participants who met specified protocol requirements; an enrolled population includes everyone enrolled, subject to the definitions used by a study. Excluding participants from a per-protocol analysis can affect how broadly its result applies, especially if exclusions relate to whether the procedure was completed. The registry defines the primary analysis set as participants who completed the required pre-ablation mapping with the investigational catheter, but it does not report how many participants were included or excluded or why.

Why does the absence of a comparison group matter?

In general, a comparison group helps distinguish an outcome associated with an intervention from outcomes that might also occur under another approach. Random assignment can help balance known and unknown differences between groups, though it does not guarantee that every source of uncertainty disappears. This study has no listed randomized comparison. Its primary endpoint also refers to the use of non-study mapping catheters as part of the success criterion, not as a separately assigned control condition. That criterion is not a substitute for a control arm.

How should adverse-event counts be read?

In general, safety summaries may count participants with events, individual events, or both, and those quantities are not interchangeable. A participant may experience more than one event, but the registry information does not say how the listed terms relate to the participant counts or whether categories overlap. The record reports serious adverse events for 4 participants and other adverse events for 1 participant, among 40 at risk in the investigational catheter group. It also lists four serious event terms with a reported percentage for each. The available figures are descriptive; a comparison, causal attribution, or event-level interpretation would require details not reported in the registry record.

What statistical plan is documented?

The record lists 15 outcome measures and 0 analyses. It does not report the statistical methods used for the primary endpoint, a sample-size justification, interim analyses, adjustment for multiple outcomes, or a missing-data method. These items should not be inferred from the endpoint wording or from the completed status. General statistical principles can explain why such choices matter, but the registry record does not establish which choices were made for this study.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Multi-electrode Electrocardiogram (ECG) Mapping Ca")
n      <- c(40)
events <- c(40)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Multi-electrode Electrocardiogram (ECG) Mapping Ca  40  40  100.0  91.2  100.0  91.2  100.0  91.4  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 15 outcome measures, including the primary mapping endpoint and secondary physician assessments of device handling, signal collection and quality, pacing, design, workflow, visualization, catheter interactions, and arrhythmogenicity. When a study evaluates multiple outcomes, the chance of observing an apparently notable result among them can increase. In general, statistical plans may address this through a prespecified hierarchy or other multiplicity procedures. The record does not report a multiplicity strategy, and it does not identify which outcomes, if any, were designated for confirmatory inference beyond the primary endpoint title.

The record lists 0 analyses. It therefore does not provide analysis-specific estimates or tests for the outcomes. The absence of those results also means the reader cannot assess whether secondary assessments were analyzed as counts, how their response criteria were defined, or how uncertainty was summarized. The list of outcomes alone does not establish that each was analyzed or that any particular analysis was planned.

Missing-data methods are not reported in the registry record. The primary analysis population is described as per-protocol and includes participants who completed the required pre-ablation mapping with the investigational catheter. The record does not report the number included in that analysis, the number who did not complete mapping, reasons for non-completion, or how unavailable endpoint information was handled. These details matter because an analysis restricted to protocol completers can differ in interpretation from an analysis of all enrolled participants.

A sample-size justification and any interim analyses are not reported in the registry record. No statistical plan should be inferred from enrollment alone. Without outcome counts, analysis denominators, and methods for missing observations and multiplicity, readers cannot evaluate precision, robustness, or the scope of statistical claims for the primary and secondary outcomes.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: atrioventricular block (2.5%), cardiac tamponade (2.5%), pericardial effusion (2.5%), transient complete atrioventricular block (2.5%).

The registry reports safety counts for the investigational catheter group. There were 40 participants at risk for serious adverse events and 4 participants affected; 40 were at risk for other adverse events and 1 was affected. The record reports 0 deaths. These are counts of participants, not necessarily counts of individual event episodes. The registry does not provide enough detail to determine whether any participant experienced more than one event or how the listed event terms correspond to the participant counts.

Four serious adverse event terms are listed, each with a reported value of 2.5%: atrioventricular block, cardiac tamponade, pericardial effusion, and transient complete atrioventricular block. Those term-level percentages should be read as the registry presents them, without assuming that the terms represent mutually exclusive participants or that they can be added together. The record does not give event narratives, onset timing, duration, resolution, or further clinical context.

These figures describe events recorded for the study group; they do not establish that the catheter caused an event. The registry information does not provide an external or randomized safety comparator, and it does not report a causal assessment method. The serious and other adverse-event counts are therefore descriptive safety information, not a comparative estimate of risk.

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

The study asks whether clinically indicated mapping could be completed with the investigational catheter, without resort to non-study mapping catheters, among participants who completed the protocol-required pre-ablation mapping. The registry record defines this primary endpoint and identifies its per-protocol population. It does not report the number of participants meeting the endpoint. Accordingly, the posted information does not establish the observed performance result or its precision.

The record does show that the study was completed, with enrollment of 40, and it lists adverse-event counts for the investigational catheter group. Those safety figures describe participants recorded with serious and other adverse events and the reported serious event terms. They should not be taken as evidence of causation, because the record does not provide a causal assessment or a control group. Nor can the single-group design establish comparative safety relative to another mapping approach.

The design and reporting also limit the questions that can be answered. There is no randomized comparison listed, no reported primary endpoint estimate, no confidence interval, and no analysis method. The registry does not report condition-specific results, details of missing endpoint information, or how the secondary physician assessments were analyzed. The intended clinical scope includes several atrial and ventricular arrhythmia conditions, but the record does not show whether results were consistent across them.

In general, a procedural performance endpoint can inform whether a device was used to complete a defined mapping task. It does not automatically establish broader clinical benefit, comparative effectiveness, or performance in settings not represented in the study. The available record supports a description of the study question and selected safety observations, but it is insufficient to answer how often the primary endpoint was met or how that result should be generalized.

14. Why This Trial Matters Statistically

This study illustrates a distinction between a well-specified statistical question and a reported statistical result. The primary endpoint has a concrete procedural criterion: mapping requirements are completed with the investigational catheter without resort to non-study mapping catheters. Yet the registry record does not report the number of participants who met that criterion. A reader can understand what was intended to be counted without being able to evaluate the observed outcome.

The single-group design also illustrates why study structure shapes interpretation. Observations from a device group can describe use and recorded events in that group. They cannot directly quantify a contrast with another device when no comparison group is listed. This distinction is important even when an endpoint includes a reference to non-study catheters: that wording defines the endpoint criterion, but does not create an assigned control group.

The record further shows why analysis populations and missing-data rules are not administrative details. The primary population is defined by completion of protocol-required mapping with the investigational catheter, but the size of that set and the handling of participants who did not complete the procedure are not reported. Without those details, the denominator and the potential effect of exclusions cannot be assessed.

Finally, a completed study record and descriptive safety counts do not replace endpoint estimates and uncertainty measures. Reporting the primary result, its analysis population, and the methods used would be necessary to judge how precisely the study answers its stated performance question. This is a statistical reporting issue, separate from any judgment about the device.

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 primary endpoint result is not reported in the registry record, so the main performance question cannot be answered from the posted information. Although enrollment was 40, the number included in the per-protocol analysis set is not reported. The record also does not provide an endpoint estimate, confidence interval, or test result.

The study is listed as single-group, with allocation NA and masking none. No randomized comparison group is identified, limiting comparative interpretation. The primary criterion’s reference to non-study mapping catheters is part of the endpoint definition and does not provide a concurrent control condition.

The record lists multiple arrhythmia conditions and atrial and ventricular procedures but does not report condition-specific outcomes. It is therefore not possible to assess whether the endpoint or safety observations differed across these settings. The registry also does not report the details needed to evaluate participant flow, endpoint classification for incomplete procedures, or missing data.

Although 15 outcome measures are recorded, the registry lists 0 analyses. Statistical methods, multiplicity handling, sample-size justification, and interim analyses are not reported in the registry record. Safety reporting is limited to participant counts, selected serious event terms, and the reported percentages. Event-level context, timing, causal assessment, and a comparator are not reported. These limits mean the available information supports descriptive study characterization, but not a detailed assessment of performance, precision, or comparative safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter — NCT05373862.
• Registry record last updated 2025-03-03; status last verified 2025-02.
• Results first posted 2024-03-13.
• 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

NCT05373862 is a completed, single-group study of a globe-shaped, high-density, multi-electrode mapping catheter sponsored by Biosense Webster, Inc. Enrollment was 40. The study began on 2022-07-29, with primary completion on 2023-02-20. The listed purpose was to assess catheter performance and safety for intracardiac mapping in atrial and ventricular procedures.

The primary endpoint counts participants whose required pre-ablation mapping and clinically indicated mapping were completed using the investigational catheter without resort to non-study mapping catheters. The primary analysis population is described as per-protocol. The endpoint count and statistical analyses are not reported in the registry record. Safety figures list 4 participants with serious adverse events, 1 with other adverse events, and 0 deaths among 40 at risk in the investigational catheter group.