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 Multipolar Mapping and Atrial Arrhythmias (NCT02307188), a na na study. The primary outcome is Atrial Fibrillation Dominant Frequency.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02307188 |
| Phase | NA |
| Condition | Atrial Fibrillation or Atrial Flutter |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Angelo Biviano |
| Results posted | Yes |
2. Clinical Question
Population
Patients with atrial fibrillation or atrial flutter undergoing ablation procedures. The registry lists an enrollment of 5. It says the one patient who completed the study did not have electrogram data of sufficient quality for the planned outcome analysis.
Intervention
The Constellation Full Contact Mapping catheter, described as a multipolar catheter, was used to collect atrial electrograms in the left and right atria.
Comparator
No comparator group is listed. The record describes a single-group study, not a like-for-like comparison between treatments or devices.
Primary question
The planned question was whether dominant frequency could be assessed from atrial fibrillation electrograms collected by the catheter and correlated with patient outcomes. The registry says the endpoint was not analyzed because the data for the patient who completed the study were insufficient.
In general, a mapping catheter collects electrical signals from within the heart, and signal analysis can characterize features of those recordings. The registry’s stated aim was to explore atrial signal characteristics that could guide atrial fibrillation and atrial flutter ablation procedures more effectively. That is the study’s rationale, not a reported finding that the device changed procedural decisions or patient outcomes.
The record does not report an analyzed relationship between dominant frequency and outcomes. With no analyzed primary endpoint and no comparator, the record cannot establish whether signal characteristics differed between groups, whether they were associated with outcomes, or whether use of the catheter improved an ablation procedure. The clinical question is therefore best understood as an exploratory measurement question, rather than a comparative assessment of clinical benefit.
3. Trial Design
The registry identifies this as a completed, single-group study with an enrollment of 5. Allocation is listed as NA and masking as NONE. The record does not describe a randomized allocation or a masked comparison. Its arm description identifies a Basket Catheter group using the Constellation Full Contact Mapping catheter to collect atrial electrograms; this is not a separate control arm.
The study concerns patients with atrial fibrillation or atrial flutter undergoing ablation procedures. The intervention is a device: the Constellation Full Contact Mapping catheter. The brief description says it was used in the left and right atria to explore atrial signal characteristics. The registry lists the study phase as NA and classifies the study kind as other.
The registry gives a start date of 2014-11 and a primary completion date of 2015-12. Its status is COMPLETED. Those record details describe the study’s administrative timing and status; they do not establish that the planned endpoint was successfully measured or analyzed. Indeed, the primary outcome description says that data from the patient who completed the study were not of sufficient quality for analysis.
Because there is no listed comparator, results cannot be interpreted as a treatment or device contrast. A single group can describe observations collected under its study procedures, but without a comparison group it cannot separate the effects of the device or procedure from other influences. In this record, the primary outcome was not analyzed, so even a descriptive dominant-frequency estimate is not reported.
The registry does not report the protocol, eligibility criteria, recruitment details, or a statistical analysis plan. Those details cannot be inferred from the study’s completed status, its enrollment, or its stated objective.
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 | Basket Catheter |
|---|---|
| STARTED | 5 |
| COMPLETED | 1 |
| NOT COMPLETED | 4 |
Analysis population for the primary outcome, as defined in the registry: Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.
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: Due to the paucity and lack of quality of intracardiac electrogram information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further.
| Characteristic | Unit | Basket Catheter |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Atrial Fibrillation Dominant Frequency, measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Atrial Fibrillation Dominant Frequency.” Its description says electrogram signal analysis would assess the dominant frequency of atrial fibrillation electrograms collected by the catheter and that these values would be correlated with patient outcomes. The timeframe is listed as 1 year.
In general, dominant frequency refers to the frequency that is most prominent in a signal under a specified analysis method. Describing a signal in this way can help characterize its electrical activity. The clinical rationale in the registry is to explore atrial signal characteristics that might inform ablation procedures; the planned outcome also refers to examining a relationship with patient outcomes.
The registry states that the outcome was not analyzed because the quality of the intracardiac electrogram data for the one patient who completed the study was insufficient. It does not report a dominant-frequency value, a correlation with patient outcomes, or an analysis method for extracting the frequency. The endpoint’s title and planned purpose should therefore not be mistaken for an observed result.
The registry does not report the specific patient outcomes to be correlated, how they were defined, or whether the listed timeframe refers to signal collection, outcome follow-up, or both. Without an analyzed signal and a reported outcome association, the record does not answer whether dominant frequency was related to patient outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the planned primary outcome was not analyzed. The registry attributes this to insufficient quality of the intracardiac electrogram data for the one patient who completed the study. Consequently, the record contains no reported dominant-frequency estimate and no reported analysis relating that measure to patient outcomes. There is no numerical effect estimate to interpret for the primary question.
The study is listed as single group, and no comparator is described. That means the study was not set up in the registry record as a like-for-like comparison between a device group and a control group. Even if a signal measure had been reported, a single-group observation would not by itself show that use of the catheter caused a difference in clinical outcomes. Here, the planned signal endpoint itself was not analyzed.
The record lists an enrollment of 5, while the outcome description specifically identifies the electrogram data for the patient who completed the study as insufficient. These details should not be collapsed into an assumed analyzed sample. The registry does not report an analyzed population for the primary outcome because it says that outcome was not analyzed. It also does not give reasons for the difference between enrollment and completion or describe data availability for other enrolled participants.
In general, an estimate describes the observed quantity, while an uncertainty interval communicates how imprecisely that estimate may be known under the analysis assumptions. No estimate or confidence interval for dominant frequency is reported, so there is no precision assessment to make for this endpoint. Likewise, no inferential analysis result is listed in the registry record. The record therefore offers no basis for judging whether a signal-outcome association was large, small, or compatible with a range of values.
The adverse-event figures are separate from the primary efficacy or signal question. The record lists 0 serious adverse events among 5 at risk and 0 other adverse events among 5 at risk in the Basket Catheter group. These counts describe the registry’s reported safety entries; they do not fill the missing primary endpoint or establish a comparison of safety with another group.
The registry’s completed status should not be read as evidence that all planned analyses were completed. The primary outcome description explicitly states that it was not analyzed, and the record lists 0 analyses. The result is therefore an incomplete statistical answer to the stated signal-analysis question, rather than a null finding. A missing estimate is not evidence that the underlying signal feature or its relationship with outcomes is absent.
Any planning illustrations based on an observed effect should be interpreted as planning calculations, not as power achieved by this study or evidence of an observed effect. The primary endpoint was not analyzed, and the record does not describe a two-arm clinical comparison. The record also does not report a sample-size justification for the study itself.
9. Statistical Methods Explained
The appropriate statistical interpretation begins with the design. The registry describes a single-group study, with allocation listed as NA and masking as NONE. The intervention is a multipolar catheter used to collect atrial electrograms. No control group or randomized comparison is listed. The study therefore does not supply a direct between-group contrast for the primary question.
What would a dominant-frequency analysis describe?
In general, a signal can be represented as a mixture of oscillatory components. A dominant-frequency analysis seeks the frequency that is most prominent under the selected signal-processing procedure. This can provide a compact description of electrical activity, but the value depends on the recorded signal and the method used to process it. Decisions such as which segments to analyze, how to handle noise, and how to define the dominant component are part of a reproducible analysis. The registry record does not report those details.
The planned endpoint concerns atrial fibrillation electrograms collected by the catheter. The registry says these values would be correlated with patient outcomes. In general, a correlation describes how two measured quantities vary together; it does not by itself establish that one quantity caused the other. Interpretation would also depend on the definitions and measurement quality of both quantities. The registry does not report an analyzed dominant-frequency measure, an outcome association, or the specific patient outcomes intended for correlation.
Why does the data-quality statement matter?
Measurement quality is fundamental to signal analysis: if the recording is not suitable for analysis, a numerical feature may not be reliably estimated. The registry explicitly says the intracardiac electrogram data for the one patient who completed the study were not of sufficient quality for the primary outcome analysis. It does not report a value for that patient, a quality threshold, or a procedure for recovering or replacing unusable recordings. The record consequently supplies no analyzed endpoint estimate to summarize.
In general, missing or unusable measurements can affect both the amount of information available and the interpretation of an analysis. The reasons data are unavailable may matter, especially if they are related to the measured signal or patient outcomes. Here, the registry gives a data-quality reason for not analyzing the endpoint for the patient who completed the study, but does not describe data quality or outcome information for other enrolled participants. It also does not report an analysis population for the primary outcome.
What can uncertainty measures tell readers?
In general, a confidence interval gives a range of values compatible with the data under a statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval, while neither width nor location can be assessed without an estimate and interval. The registry record does not report a dominant-frequency estimate, confidence interval, or other precision measure. No statistical significance test for the primary endpoint is reported either.
A p-value, in general, summarizes how incompatible observed data are with a specified null model, given the analysis assumptions. It does not measure the probability that a hypothesis is true, and it does not describe the size or clinical importance of an effect. There is no primary-outcome p-value reported in this record. Since the endpoint was not analyzed, readers should not treat the absence of a reported p-value as a nonsignificant finding.
How should planning calculations be understood?
General sample-size planning asks how many participants would be needed under stated assumptions to detect a specified effect with a chosen error rate and power. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the stated effect is a fraction of an observed effect. For time-to-event calculations, the stated convention is to report total events, while other calculations are expressed as participants per arm.
These are planning assumptions, not a description of this study’s single-group design. The record does not report that participants were assigned equally between two arms, and it does not report a sample-size justification for the trial. Planning illustrations are not observed power: they do not establish what power the completed study achieved. Further, the primary outcome was not analyzed, so the record supplies no analyzed dominant-frequency effect on which to base an interpretation of an observed endpoint result.
In general, over-dispersion means that observed variability exceeds what a simpler statistical model expects. Accounting for it can affect standard errors and uncertainty estimates. The registry does not report a model for this outcome or indicate that over-dispersion was assessed. More broadly, no statistical analysis plan, model specification, handling of repeated signals, covariate adjustment, or inferential strategy is reported in the registry record. These methods should not be inferred from the endpoint title or from generic planning assumptions.
The record lists 0 analyses. Taken together with the explicit statement that the primary outcome was not analyzed, this means there is no reported analysis result to evaluate for model fit, precision, statistical significance, or robustness. General statistical concepts can clarify what such analyses would mean, but cannot substitute for an analysis that is absent from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, identified as the primary outcome, and lists 0 analyses. Its description states that the dominant-frequency measure was not analyzed because the electrogram data for the one patient who completed the study were insufficient. Thus, there are no reported primary-outcome results to interpret alongside any secondary analysis.
Multiplicity arises when multiple outcomes, time points, subgroups, or statistical tests are examined; considering many results can increase the chance of finding an apparently notable result by chance. In general, an analysis plan can specify which comparisons are primary and how multiplicity will be handled. The registry record does not report a multiplicity plan, a hierarchy of tests, or details about additional analyses. The fact that one outcome measure is listed does not establish what analyses were planned beyond the record.
The available missing-data information is limited. The outcome description says the one patient who completed the study had electrogram data of insufficient quality for analysis. It does not report the quality of recordings for other enrolled participants, reasons other participants did not complete the study, or whether any outcome data were available for them. It also does not describe an imputation method, sensitivity analysis, or other handling of unavailable measurements. Those methods are not reported in the registry record.
The record does not define a separate analysis population for the primary endpoint. Because the outcome was not analyzed, there is no reported analyzed set from which to assess how participants were included or excluded. In general, a clear account of the analysis population and missing-data handling helps readers judge whether an estimate represents the intended population. Here, no such endpoint estimate is available.
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 |
|---|---|---|---|
| Basket Catheter | 0 | 5 | 0.0% |
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 |
|---|---|
| Basket Catheter | 0 of 5 |
The registry’s Basket Catheter safety entry lists 5 participants at risk for serious adverse events and 0 affected. It also lists 5 at risk for other adverse events and 0 affected. These are the reported counts in the registry record, and the two categories should be read as separate safety summaries.
The death count is not reported in the registry record. The entry does not list any top serious-event terms. A count of 0 in the reported adverse-event fields means that the record lists no affected participants in those fields; it does not provide details about event definitions, monitoring procedures, or the completeness of event capture.
In general, safety counts describe what was recorded under a study’s definitions and observation procedures. They do not by themselves establish that an intervention is free of risk, and a single-group entry cannot provide a comparative safety estimate against a control group. These figures should also be kept separate from the primary signal-analysis result, which was not analyzed because the electrogram data for the patient who completed the study were insufficient.
12. What the Result Does, and Does Not, Mean
The record establishes that this completed, single-group investigation used the Constellation Full Contact Mapping catheter to collect atrial electrograms in the left and right atria, with the aim of exploring signal characteristics relevant to atrial fibrillation and flutter ablation procedures. Its planned primary outcome was dominant frequency, with a stated intention to relate values to patient outcomes.
It does not establish an observed dominant-frequency result. The registry says the primary outcome was not analyzed because the data for the one patient who completed the study were not of sufficient quality. No endpoint estimate, uncertainty interval, or outcome correlation is reported. The correct interpretation is that the stated endpoint question remains unanswered in this record, not that an analysis found no difference or no association.
The study also has no listed comparator group. It therefore cannot provide a direct comparison between catheter use and an alternative device or approach. More generally, observations from a single group cannot by themselves establish that an intervention caused a change in patient outcomes. The registry does not report that the catheter improved procedural guidance or patient outcomes; these are aims in the study description, not demonstrated findings.
The safety entry lists 0 serious adverse events among 5 at risk and 0 other adverse events among 5 at risk, with deaths not reported in the registry record. Those reported counts should be interpreted within the limits of the record and do not answer the primary signal question or establish comparative safety.
Accordingly, the record is most informative about the study’s objective, design, and the data-quality limitation that prevented the primary analysis. It does not establish effectiveness, lack of effectiveness, or a relationship between dominant frequency and patient outcomes.
13. Why This Trial Matters Statistically
This study illustrates a basic distinction between a planned endpoint and an analyzed result. A registry can specify a clinically motivated measurement and its intended role, but the endpoint only supports statistical interpretation if usable observations are available and analyzed. Here, the primary outcome description states that the signal data for the patient who completed the study were insufficient, and the registry reports no analyses. The planned dominant-frequency measure therefore cannot be treated as an observed finding.
The record also highlights that measurement quality is not a minor technical detail in signal-based research. A signal summary depends on the quality of the underlying recording and on the analysis method. If the recording cannot support the planned analysis, there is no reliable estimate to compare or correlate with outcomes. The registry does not report the processing details or any alternative analysis, so the specific source and extent of the data-quality problem cannot be assessed.
Design matters as well. The study is single group, with no listed comparator, while some general planning illustrations use assumptions for a two-arm design. Those assumptions are not evidence that a two-arm comparison occurred, nor do they turn planning calculations into observed power. Keeping the intended design separate from generic planning conventions prevents misleading conclusions.
Finally, the record shows why administrative completion and statistical completion are not interchangeable. The study status is COMPLETED, but its stated primary outcome was not analyzed. Readers should assess the reported evidence for each outcome rather than infer results from the status label or from the existence of a planned measure.
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 principal limitation is explicit in the registry: the primary outcome was not analyzed because the electrogram data for the one patient who completed the study were not of sufficient quality. No dominant-frequency estimate or correlation with patient outcomes is reported. The intended primary question therefore has no analyzed result in the record.
The study is listed as single group, without a comparator. This limits what the design could establish about differences attributable to the catheter, even if an outcome had been analyzed. The record also lists an enrollment of 5 but does not explain the reasons for study completion status at the participant level or describe outcome data availability for participants other than the patient identified in the primary outcome description.
Important methodological details are not reported in the registry record. These include the signal-processing procedure, data-quality criteria, specific patient outcomes for correlation, a statistical analysis plan, and an analysis population. The record does not describe handling of unavailable or unusable measurements, sensitivity analyses, or multiplicity procedures. As a result, readers cannot evaluate the robustness of an endpoint analysis or reproduce its methods.
The safety information is also limited to the reported counts: 0 serious and 0 other adverse events among 5 at risk, with the death count not reported in the registry record. The record does not describe event definitions or capture procedures. These entries should not be interpreted as a comparative safety assessment.
The registry’s COMPLETED status does not resolve these limitations. The absence of a primary outcome analysis means that no conclusion about the planned signal measure or its relationship with patient outcomes can be drawn from this record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multipolar Mapping and Atrial Arrhythmias — NCT02307188.
- Registry record last updated 2016-03-16; status last verified 2016-02.
- Results first posted 2016-03-16.
- 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.
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
NCT02307188 is a completed, single-group device study in patients with atrial fibrillation or atrial flutter undergoing ablation procedures. The Constellation Full Contact Mapping catheter was used to collect atrial electrograms in the left and right atria. Enrollment is listed as 5; allocation is NA, masking is NONE, and phase is NA.
The planned primary outcome was atrial fibrillation dominant frequency, with values intended to be correlated with patient outcomes over a timeframe of 1 year. The registry states that the outcome was not analyzed because the electrogram data for the one patient who completed the study were insufficient for analysis. The record lists 0 analyses.
The Basket Catheter safety entry reports 0 serious adverse events and 0 other adverse events among 5 at risk. Deaths are not reported in the registry record. No comparator group or primary-outcome estimate is reported.