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 An Evaluation of the Safety and Performance of the CathVision ECGenius® System. (NCT05301803), a registered phase not stated study. The primary outcome is Baseline Noise Comparison.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05301803 |
| Phase | Phase not stated |
| Condition | Cardiac Arrhythmia |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | CathVision ApS |
| Results posted | Yes |
2. Clinical Question
Population
Participants with cardiac arrhythmia undergoing assessment and ablation procedures are the clinical population described. The registry record reports enrollment of 27 participants at a single center. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention is listed as an electrophysiology procedure and categorized as a device intervention. The study evaluates the safety and technical performance of the CathVision ECGenius® System during electrophysiology procedures.
Comparator
The study is single-arm, not a randomized comparison. Its secondary objective is to benchmark intracardiac electrogram signal quality against commercially available systems. The registry description does not identify a separate control arm or provide enough detail to establish how the system-to-system measurements were organized or analyzed.
Primary question
The primary endpoint is baseline noise, measured as peak-to-peak noise in μV for bipolar and unipolar electrograms in two EP recording systems. The registry record specifies the median and inter-quartile range as the summary measures. The clinical question is whether the system's safety and technical performance can be characterized in this procedural setting, including its baseline-noise measurements. Numerical baseline-noise results and a quantified comparison between systems are not reported in the registry record.
3. Trial Design
This is a prospective, single-center, open-label, single-arm study of the CathVision ECGenius® System. The registry record lists the study as completed and reports enrollment of 27 participants. The recorded start date is 2022-03-29, and the primary completion date is 2022-04-30. The listed condition is cardiac arrhythmia.
The primary objective is to evaluate safety and technical performance. A secondary objective is to benchmark intracardiac electrogram signal quality against commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias. The intervention is described as an electrophysiology procedure and categorized as a device intervention. The record does not specify allocation, and the study is not a randomized comparison. A single-arm design does not, by itself, establish a like-for-like control comparison.
The primary outcome is titled Baseline Noise Comparison and describes peak-to-peak baseline noise in two EP recording systems, for both bipolar and unipolar electrograms. The measure is in μV, summarized by the median and inter-quartile range. Its timeframe states that EP and ablation procedures can take up to six hours. This describes the procedural context, not a separately reported follow-up duration.
The registry record does not report the detailed protocol, eligibility criteria, device-use sequence, or the method used to match or compare readings from the recording systems. The study's completed status indicates its recorded administrative status; it does not supply the missing endpoint estimates or statistical conclusions.
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 | Single Arm |
|---|---|
| STARTED | 27 |
| COMPLETED | 25 |
| NOT COMPLETED | 2 |
Analysis population for the primary outcome, as defined in the registry: Baseline noise
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 | Single Arm |
|---|---|---|
| Participants analysed | 27 | |
| Age, Continuous | Years | 63.67 (SD 7.27) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 17 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 27 |
6. Primary Endpoint
The registry lists the primary outcome as Baseline Noise Comparison, measured over EP and ablation procedures can take up to six hours.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | μV |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint measures peak-to-peak baseline noise in μV in two EP recording systems, for bipolar and unipolar electrograms. Baseline noise is unwanted electrical variation present in a signal when the signal of interest is not being recorded. In general, measuring it helps characterize the technical quality of an electrophysiology recording system: noise can affect how clearly electrical signals are distinguished from background variation. The registry identifies baseline noise as the outcome population and specifies the median and inter-quartile range for its summary.
The median represents the midpoint of the observed measurements after ordering them. The inter-quartile range describes the spread of the central portion of those measurements. In general, these summaries can be useful when measurements are skewed or include unusually high or low values, because they are less sensitive to extremes than the mean and standard deviation. They describe the measurements; on their own, they do not quantify uncertainty about a system-to-system difference.
The registry's timeframe states that EP and ablation procedures can take up to six hours. The record does not report the observed medians or inter-quartile ranges, a numerical difference between systems, or an uncertainty interval. It therefore gives the endpoint definition but not the numerical findings needed to assess the size or precision of any comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a technical endpoint and a safety objective, but it does not report numerical results for baseline noise. The endpoint description specifies measurements in μV, median and inter-quartile range summaries, and readings for bipolar and unipolar electrograms in two EP recording systems. Without the observed summaries or a reported contrast, the magnitude and direction of any difference between systems cannot be characterized from the record.
No inferential analyses are reported. There is no reported confidence interval, p-value, or model-based estimate for the primary endpoint. This means the posted record does not establish how precisely the baseline-noise measurements were estimated or whether any system-to-system difference is compatible with a range of values. It also does not support a conclusion that the systems had equivalent or different signal quality. A missing numerical result is not evidence of no difference.
The secondary objective concerns benchmarking intracardiac electrogram signal quality against commercially available systems. However, the registry record does not report numerical benchmarking results or describe a statistical comparison. The single-arm design also matters for interpretation: this is not a randomized comparison of treatment groups, and the record does not define a separate like-for-like control arm. The objective of comparing systems should not be mistaken for evidence that a particular comparative analysis was completed or reported.
For safety, the single-arm group lists 1 serious adverse event affected among 27 at risk, 0 other adverse events affected among 27 at risk, and 0 deaths. Pericardial effusion is listed among the top serious terms at 3.7%. These counts describe the recorded events in this study group. With no separate control arm reported, they do not establish a comparative safety difference. The record does not report event relatedness, detailed case information, or a statistical comparison of safety outcomes.
The registry record reports enrollment of 27 and a completed status. Enrollment and completion status do not substitute for outcome reporting. The record also lists two outcome measures but no analyses. Consequently, its contribution is chiefly to identify the study's question, design, endpoint definition, and recorded safety counts. Any conclusion about the technical performance estimate, its uncertainty, or a comparative effect would require results not reported in the registry record.
9. Statistical Methods Explained
The registry describes a prospective, open-label, single-arm study and specifies the primary endpoint as peak-to-peak baseline noise in μV. It names the median and inter-quartile range as the summary measures. No inferential analyses are reported. The following explanations are general statistical interpretation, not claims that these procedures were used in this study.
What do the median and inter-quartile range describe?
General: The median is the central value when observations are ordered. The inter-quartile range describes the spread of the middle half of those observations. These summaries can communicate a typical measurement and its variability without assuming that measurements follow a symmetric distribution. A median and inter-quartile range do not, by themselves, show the precision of an estimate or test a difference between systems. To assess precision, readers would generally need an uncertainty measure, such as a confidence interval, along with clear information about the observations included.
The endpoint includes bipolar and unipolar electrograms and measurements from two EP recording systems. General: those categories can matter because a single overall summary might conceal variation across signal type or system. A clear report would identify which measurements were summarized together and which were reported separately. The registry description does not report that level of detail or the observed summaries.
What would a system comparison require?
General: a comparison depends on the design and structure of the measurements. If measurements from the systems were taken on the same participant or under matched conditions, an analysis might account for their pairing. If measurements were independent, a different approach might be appropriate. These are conditional examples, not descriptions of this study's analysis. The registry record does not state whether measurements were paired, how many observations contributed to each summary, or what method was used to compare systems.
A point estimate of a difference would describe the contrast on the measurement scale, while a confidence interval would show the range of values reasonably compatible with the data under the model. A p-value, if reported, would address compatibility with a specified null model; it would not measure the probability that the null hypothesis is true or establish technical importance. None of these inferential results is reported for the primary endpoint, so no such interpretation can be made from the record.
How should the planning illustration be read?
General: sample-size calculations depend on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. The planning illustration associated with this study uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. For time-to-event calculations, it expresses the requirement as a total number of events; for other calculations, it expresses participants per arm.
Those assumptions describe a planning illustration, not the actual design of this single-arm study. In particular, an equal-allocation, two-arm calculation is not evidence that the trial enrolled randomized arms. The registry record reports 27 enrolled participants and does not report a trial-specific sample-size justification. Planning estimates are not observed power and do not show that an effect was detected. No numerical sample-size requirements are because the registry record does not state them in the registry record describing this study.
What does the absence of analyses imply?
General: an analysis plan typically clarifies the estimand, the population included, handling of missing measurements, methods for estimating uncertainty, and any adjustments for multiple outcomes or comparisons. These choices affect how a result should be interpreted. The registry record reports no analyses and does not report those details. It is therefore not possible to determine from the record whether the measurements were adjusted, whether any model was used, or how uncertainty and incomplete observations were handled.
Over-dispersion is a general concern when count data vary more than a chosen probability model expects. It is not a specific reported issue for this continuous baseline-noise endpoint, and the registry record does not identify an over-dispersion model. More broadly, statistical methods should follow the measurement structure and study question. The available description establishes the endpoint summaries and study design, but not the actual analytic procedures or their results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures, but it does not report an analysis count, a statistical analysis plan, or a multiplicity adjustment. General: when several outcomes, signal types, or comparisons are tested, the chance of at least one nominally unusual result can increase. A prespecified hierarchy or adjustment can address that issue, but neither should be assumed without documentation. The record also does not state whether bipolar and unipolar measurements were treated as separate tests, combined summaries, or descriptive measures.
Missing-data handling is not reported in the registry record. It does not state whether any baseline-noise measurements were missing, how incomplete procedures were handled, or whether measurements were excluded. General: missingness can affect estimates if the availability of a measurement is related to its value or to participant and procedural characteristics. A complete report would describe the amount and pattern of missingness and explain the analysis population used.
The analysis population is also not reported in the registry record. Enrollment of 27 is not enough to establish how many participants contributed to the primary endpoint or safety summaries. The record does not identify a per-protocol, full analysis, or other analysis set, and it does not describe exclusions. No primary endpoint analyses are reported. As a result, neither multiplicity control nor the handling of missing observations and analysis populations can be evaluated from the registry record.
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 |
|---|---|---|---|
| Single Arm | 1 | 27 | 3.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Single Arm | 0 of 27 |
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 |
|---|---|
| Single Arm | 0 of 27 |
Most frequent serious adverse event terms
| Event term | Organ system | Single Arm |
|---|---|---|
| Pericardial effusion | Cardiac disorders | 1 of 27 |
Serious events with the highest arm-level rate: pericardial effusion (3.7%).
The single-arm group lists 27 participants at risk for serious adverse events, with 1 affected. It lists 27 at risk for other adverse events, with 0 affected, and records 0 deaths. Pericardial effusion appears among the top serious adverse event terms at 3.7%. These figures are descriptive counts in the recorded study group, not estimates from a comparison with a control group.
The 3.7% value is reported for the listed term. The registry record does not provide further case details, the timing or duration of the event, or whether the event was judged related to the system or procedure. A serious adverse event is not necessarily caused by an intervention; attribution requires information about the event and the study's assessment process. Such attribution is not reported in the registry record.
Zero recorded other adverse events or deaths does not establish that the risk of such events is zero. It means only that the registry lists no affected participants in those categories for this group. The enrollment of 27 also means that these counts should be read in the context of a small, single-arm study, without treating them as a comparative safety estimate. The registry record does not report a statistical analysis of safety outcomes.
12. What the Result Does, and Does Not, Mean
The study addresses a relevant technical question: how baseline noise is characterized in two EP recording systems during electrophysiology procedures, across bipolar and unipolar electrograms. The registry specifies a median and inter-quartile range and identifies safety and technical performance as primary objectives. It also describes a secondary objective of benchmarking intracardiac electrogram signal quality against commercially available systems.
What the posted record does not establish is the numerical baseline-noise result. It reports neither the median and inter-quartile range values nor a system-to-system estimate, confidence interval, or p-value. Therefore, the magnitude, direction, and precision of a difference cannot be judged from the registry record. The absence of numerical results should not be interpreted as evidence that the systems performed the same or differently.
The design limits comparative interpretation. This is a single-arm study, not a randomized comparison, and the record does not identify a separate control arm. The stated benchmarking objective does not by itself show that a controlled comparison was performed or that any comparison was adjusted for relevant factors. The results needed to evaluate that objective are not reported in the registry record.
The safety counts document 1 serious adverse event affected among 27 at risk, 0 other adverse events affected among 27 at risk, and 0 deaths. Pericardial effusion is listed at 3.7% among the top serious terms. Those details describe recorded events, but do not establish causation or comparative risk. Event attribution and detailed safety analyses are not reported.
Overall, the registry record is informative about the study question, setting, design, endpoint definition, and recorded safety counts. It is not sufficient to quantify the primary endpoint or establish a statistical conclusion about technical performance. The completed status is an administrative status, not a substitute for reported results.
13. Why This Trial Matters Statistically
This study illustrates a common distinction in clinical research between defining a technical endpoint and reporting evidence about that endpoint. Baseline noise is specified in concrete terms: peak-to-peak measurements in μV, for bipolar and unipolar electrograms, with median and inter-quartile range summaries. That definition helps readers understand what was intended to be measured. Without the observed summaries and an uncertainty estimate, however, the statistical evidence about performance cannot be assessed.
The design is also important to statistical interpretation. A single-arm study can describe measurements and events in its enrolled group, but it does not automatically supply a randomized control comparison. A secondary benchmarking objective is not equivalent to a reported comparative analysis. Explicit information about measurement pairing, system assignment, analysis populations, and comparison methods would be needed to understand the strength and limits of any benchmark.
The record also separates safety description from causal inference. Counts of events and deaths are useful parts of a safety profile, but a small single-arm record cannot by itself distinguish study-related events from the background occurrence of events in the procedural setting. Event attribution, follow-up, and comparison details matter, and are not reported in the registry record.
Finally, the record demonstrates why registry status and analysis results must be read separately. The study is marked completed and reports enrollment of 27, but no primary endpoint analyses are reported. That makes the endpoint definition and safety counts useful descriptive information while leaving the central technical-performance estimate unresolved. Statistically, the missing numerical result is itself a key limit on what can be concluded.
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 that numerical primary endpoint results are not reported in the registry record. Although the outcome definition gives the measurement scale and summary statistics, observed medians and inter-quartile ranges are absent. No system-to-system estimate or uncertainty interval is reported, so the size and precision of any contrast cannot be assessed.
The single-center, single-arm design limits the scope of inference. Enrollment was 27, and no separate control arm is described. Although the secondary objective refers to benchmarking against commercially available systems, the record does not detail the comparison structure, system assignment, or whether measurements were paired. It is therefore not possible to assess the comparability of the measurements or the analysis used for benchmarking.
Further study details are not reported in the registry record, including eligibility criteria, participant characteristics, the analysis population, missing-data methods, and multiplicity handling. The timeframe says procedures can take up to six hours, but the record does not establish a separate follow-up duration for safety events. Event relatedness and case details are also not reported. These omissions limit interpretation of both technical performance and safety.
The registry records completion, but does not include inferential analyses for the primary endpoint. It also does not report a trial-specific sample-size justification. A planning illustration based on an observed effect is not a substitute for a documented design rationale or a reported result, and its two-arm assumptions should not be mistaken for this study's single-arm design.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Evaluation of the Safety and Performance of the CathVision ECGenius® System. — NCT05301803.
- Registry record last updated 2024-09-05; status last verified 2024-08.
- Results first posted 2024-09-05.
- 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.
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18. Record Summary
The record describes a prospective, single-center, open-label, single-arm study evaluating the safety and technical performance of the CathVision ECGenius® System. The listed condition is cardiac arrhythmia; enrollment is 27, and study status is completed. The recorded start date is 2022-03-29, and primary completion is 2022-04-30.
The primary endpoint measures peak-to-peak baseline noise in μV in two EP recording systems, for bipolar and unipolar electrograms. The specified summaries are the median and inter-quartile range. The secondary objective is to benchmark intracardiac electrogram signal quality against commercially available systems. The registry record reports no primary endpoint analyses or numerical noise results.
The single-arm safety group lists 1 serious adverse event affected among 27 at risk, 0 other adverse events affected among 27 at risk, and 0 deaths. Pericardial effusion is listed among the top serious terms at 3.7%. The record does not report event attribution or comparative safety analyses.