Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation (NCT04580914), a na na study. The primary outcome is Rate of Primary Safety Events at 1-Month Post-Procedure.

2. Clinical Question

3. Trial Design

The registry record describes NEwTON AF as a multi-center, global, prospective, single-arm study evaluating the IntellaNav StablePoint Catheter and Force-Sensing System. Its stated purpose was to establish safety and effectiveness in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation. The listed intervention is treatment with the IntellaNav StablePoint Ablation Catheter. The study status is completed, and the record lists 321 participants enrolled. The study start was 2021-04-12, and primary completion was 2023-06-21. The design has one treatment group, with no randomized or concurrent control group listed. Allocation is recorded as NA and masking as none. The record gives the primary safety result for 299 treatment subjects. It does not explain why this analysis count differs from the overall enrollment count, nor does it report the criteria used to enter the primary safety analysis population. Those details are not reported in the registry record. The primary outcome is described as the rate of primary safety events at 1-Month post-procedure, with a timeframe up to 30 days. The result is expressed as 13 primary safety events occurring in 12 subjects through 30 days. Several additional outcomes are listed, including adverse events through 12-months post-procedure, antiarrhythmic drug use, freedom from primary effectiveness failure without repeat procedure, and rhythm recurrence. Numerical findings for those outcomes are not reported in the registry record. The record also does not provide a randomized treatment contrast, masking procedures, or a detailed statistical analysis plan.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: A total of 299 subjects were enrolled in the NEwTON AF study and subsequently classified as Treatment subjects undergoing an ablation procedure with the Investigational IntellaNav™ StablePoint Catheter System. Of the Treatment subjects, eight (8) were lost to follow-up (2 subjects) or withdrew from the study prior to study completion (6 subjects).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Of the 299 treatment subjects, a total of 13 primary safety events occurred through 30 days in 12 subjects.

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: Treatment Subjects

6. Primary Endpoint

The registry lists the primary outcome as Rate of Primary Safety Events at 1-Month Post-Procedure, measured over Up to 30 Days.

The primary endpoint is titled the rate of primary safety events at 1-Month post-procedure, with the timeframe specified as up to 30 days. Its description defines the primary safety endpoint as the safety-event-free rate at 1-Month (30 days) post-procedure. The posted result gives the event count and the number of subjects with events: 13 events occurred in 12 of the 299 treatment subjects through 30 days. Counting both events and affected subjects is useful because these are different summaries. One subject can experience more than one event, so the event total need not equal the number of subjects who experienced an event. In this result, the registry reports both quantities rather than only one. It does not provide the event-free rate as a numerical estimate, a confidence interval, or a comparison with another group. No calculation of those quantities should be inferred from the count alone. In general, a short-term safety endpoint can describe the occurrence of specified safety events during a defined period after a procedure. The endpoint’s usefulness depends on how events are defined, identified, and assessed, as well as on the length of follow-up. The registry record does not give further operational details about the primary safety-event definition, adjudication, or completeness of follow-up.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry’s primary outcome is expressed as a number of events and is accompanied by the number of subjects who experienced them. These are descriptive summaries. An event count records occurrences, whereas a subject count records people with at least one occurrence. A person can contribute more than one event, so the quantities answer different questions. The posted result gives 13 primary safety events in 12 subjects through 30 days among 299 treatment subjects. The registry does not report a model-based estimate or an inferential analysis for this endpoint. In general, a rate or proportion needs a clearly defined numerator and denominator, and its interpretation depends on how observation time and follow-up are handled. The endpoint title uses the word rate, while the description refers to the safety-event-free rate. The posted result itself gives event and subject counts, rather than a numerical safety-event-free estimate. No additional calculation is presented in the registry record, so the counts should be reported as counts rather than converted into a rate or percentage. A confidence interval is a statistical expression of uncertainty around an estimate under a specified method. It can help readers judge how precisely a result is estimated, but it does not correct for bias, establish causation, or make unlike groups comparable. No confidence interval for the primary endpoint is reported in the registry record. A p-value or other inferential test for that endpoint is also not reported. In the absence of those quantities, the result is descriptive and its statistical precision cannot be assessed from the posted endpoint entry. The study is single group and has no listed comparator. In general, a single-group design can describe outcomes among participants who received the intervention, but it cannot isolate an intervention’s effect from other explanations for the observed outcomes. A comparison against a separate study or historical experience would require careful attention to differences in participant selection, endpoint definitions, follow-up, and clinical practice. The registry record does not describe a formal external comparison, and none should be inferred from the posted result. The registry lists 321 participants enrolled and gives the primary safety result for 299 treatment subjects. These are the recorded overall enrollment and result population figures. The record does not state the analysis-population rules, the number with complete follow-up, or the reasons that the figures differ. In general, an analysis population is defined by rules about eligibility, treatment received, and outcome availability. Those rules matter because different choices can affect the interpretation of an estimate. Here, the primary safety result should be attributed specifically to the 299 treatment subjects, without assumptions about the remaining enrolled participants. The listed secondary outcomes include adverse-event rates through 12-months post-procedure, the number of participants with a new or increased dose of antiarrhythmic drug, freedom from primary effectiveness failure without repeat procedure, and freedom from documented symptomatic atrial fibrillation, atrial flutter, and atrial tachycardia recurrence. They address distinct questions and time horizons. Numerical results for these outcomes are not reported in the registry record. The outcome list alone does not establish that the outcomes were analysed, nor does it describe the statistical methods used for them. In general, a prespecified analysis plan identifies outcome definitions, populations, models, and methods for handling missing observations before results are examined. It can reduce ambiguity about which analyses are primary and how choices are made. The registry record does not report detailed methods for the primary endpoint, including event adjudication, a statistical model, or a missing-data procedure. It also does not report interim analyses or a sample-size justification. No such methods should be assumed. Multiplicity refers to the interpretive issue created when several outcomes or hypotheses are assessed. In general, considering many tests can increase the chance that at least one appears notable by chance, and methods such as adjustment or a hierarchy of testing may be used to address that issue. The registry lists multiple secondary outcomes but does not report a multiplicity strategy. Since the numerical secondary results and analysis details are not reported in the registry record, the extent to which any multiplicity procedure was used cannot be assessed.

10. Multiplicity, Missing Data and Analysis Populations

Several secondary outcomes are listed alongside the primary safety endpoint. They cover adverse events over a longer follow-up period, antiarrhythmic drug use, freedom from a primary effectiveness failure without repeat procedure, and rhythm recurrence. In general, assessing multiple outcomes raises a multiplicity question: when many statistical tests are performed, the chance of at least one apparently notable result can increase. A prespecified hierarchy or adjustment can help control that issue, but the registry record does not report whether such a strategy was used. The secondary outcome list alone is not evidence that every outcome was analysed, and their numerical results are not reported in the registry record. The record reports 321 participants enrolled and a primary safety result for 299 treatment subjects. It does not state how analysis populations were defined, why the counts differ, or how participants without outcome data were handled. Missing-data methods, completeness of follow-up, and any sensitivity analyses are not reported in the registry record. These omissions limit assessment of whether the posted count reflects all participants intended for the primary safety analysis and whether missing observations could affect its interpretation. In general, missing outcomes can matter when their absence is related to participant characteristics or clinical events. Statistical methods may use assumptions or sensitivity analyses to examine how conclusions change under different missing-data scenarios. Those methods cannot be attributed to this study based on the posted record. The record also does not identify an intention-to-treat, per-protocol, or other named analysis population. Accordingly, interpretation should remain anchored to the reported count among 299 treatment subjects and should not presume an unreported population rule or missing-data approach.

11. 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: pericarditis (2.0%), atrial fibrillation (af) (1.3%), musculoskeletal (1.3%), pulmonary (1.3%), pericardial effusion (1.0%).

The registry’s adverse-event entry reports 47 participants with serious adverse events and 64 with other adverse events, each among 299 participants at risk in the treatment group. These are separate categories in the registry entry and should not be added together to produce a number of unique participants: the record does not state whether any participants appear in both categories. It also reports 0 deaths. These figures are adverse-event summaries and are distinct from the primary safety endpoint count of 13 events in 12 subjects through 30 days. The most frequent listed serious adverse-event terms are Pericarditis at 2.0%, Atrial Fibrillation (AF) at 1.3%, Musculoskeletal at 1.3%, Pulmonary at 1.3%, Pericardial Effusion at 1.0%, and Gastrointestinal at 1.0%. The registry record does not clarify in this entry whether each term represents a participant count, how terms were grouped, or whether events were judged related to the device or procedure. These percentages describe the posted serious-event terms and should not be interpreted as proof of causation. The adverse-event summary does not provide individual event narratives or explain overlap among terms. It also does not replace the primary endpoint definition or establish the completeness of reporting. The registry lists a secondary outcome concerning adverse events through 12-months post-procedure, but its numerical result is not reported in the registry record.

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

The result shows that the registry recorded 13 primary safety events in 12 of 299 treatment subjects through 30 days. It also shows that the study was a prospective, single-group evaluation of the StablePoint catheter and force-sensing system in people described as having symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation. These registry entries characterize what was studied and what was recorded; they do not establish a treatment effect relative to another approach. The primary endpoint description refers to a safety-event-free rate, but the posted result gives event and subject counts rather than a numerical event-free rate. No confidence interval is reported to convey the precision of an estimate. The registry also does not provide a detailed definition or adjudication procedure for the primary safety events. Those limitations make it difficult to assess how broadly the count can be interpreted beyond the reported endpoint and follow-up period. The absence of a control group is consequential for interpretation. In general, observing events after a procedure does not establish that the procedure caused them, and observing an outcome in a treated group does not show what would have occurred under an alternative. A controlled comparison can support a different kind of inference, subject to its own assumptions and limitations. This single-group record does not make that comparative estimate. The result also does not answer every question named in the study purpose. The registry lists effectiveness-related and longer-term safety outcomes, but their numerical findings are not reported in the registry record. The primary safety count should therefore not be treated as a complete summary of effectiveness, recurrence, medication use, or later adverse events. Nor does the count alone indicate whether an event was serious, device-related, procedure-related, or clinically consequential; the primary endpoint entry does not provide those details. The appropriate statistical reading is bounded: the record documents a specific number of events and affected subjects in a stated treatment population and time window. It does not provide the comparative evidence, uncertainty estimates, or further endpoint detail needed to make broader claims. This interpretation concerns the posted registry data and is not medical advice.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a descriptive single-group result and a comparative treatment estimate. The registry reports a count of primary safety events and a count of affected subjects, each of which has a distinct interpretation. Keeping those quantities separate avoids confusing repeated events with the number of people who experienced an event. The record also makes the denominator issue visible: it reports 321 participants enrolled overall, while the primary safety result is for 299 treatment subjects. That difference is not explained in the registry record. Recognizing that distinction is important because a result must be interpreted in relation to the population actually described for the outcome, rather than an assumed analysis population. The endpoint is framed as a safety-event-free rate, yet the posted numerical result is an event count and affected-subject count. No estimate of the event-free rate, confidence interval, or inferential test is reported. This illustrates why a label and a reported result are not interchangeable: readers need the actual estimate, its denominator, and its uncertainty to assess precision. The trial’s single-group design further defines what can be learned. It can describe outcomes recorded in the treated participants, but it does not estimate a difference against a concurrent comparator. The listed secondary outcomes indicate additional domains of interest, while their numerical findings and analysis methods are not reported in the registry record. Taken together, these features make the record useful for understanding the structure and limits of registry-based evidence, without supporting a causal or comparative conclusion.

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 primary endpoint result is limited to 13 events in 12 of 299 treatment subjects through 30 days. The registry record does not provide a numerical safety-event-free rate, confidence interval, or inferential test. It does not give the detailed definition of primary safety events, describe event adjudication, or identify whether events were attributed to the device or procedure. The result therefore has limited interpretive detail beyond the counts and timeframe stated. The single-group design has no listed concurrent comparator, so the posted result does not estimate a comparative effect. The registry does not report whether participants were selected under additional eligibility criteria beyond the description of symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation. It also does not explain the relationship between 321 participants enrolled and 299 treatment subjects in the primary result. Analysis-population rules and reasons for the difference are not reported in the registry record. The record lists outcomes relating to longer-term adverse events, medication changes, effectiveness failure, and recurrence, but their numerical findings are not reported. Missing-data procedures, follow-up completeness, sensitivity analyses, multiplicity methods, and the detailed statistical analysis plan are also not reported in the registry record. The record does not provide a sample-size justification or interim-analysis details. These absences prevent assessment of how the outcome estimates were planned, how unobserved outcomes were handled, and whether findings across multiple outcomes were interpreted under a prespecified framework.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation — NCT04580914.
• Registry record last updated 2025-01-16; status last verified 2025-01.
• Results first posted 2025-01-16.
• 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.

18. Record Summary

The registry record describes a completed, prospective, multi-center, global, single-group study of the IntellaNav StablePoint Ablation Catheter and Force-Sensing System for symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation. It lists 321 participants enrolled and a primary safety result for 299 treatment subjects. Through 30 days, 13 primary safety events occurred in 12 subjects. The endpoint description refers to a safety-event-free rate, but no numerical rate estimate or confidence interval is reported. The adverse-event entry lists 47 participants with serious adverse events, 64 with other adverse events, and 0 deaths among 299 at risk. Several secondary safety and effectiveness outcomes are listed, but their numerical results are not reported in the registry record. No control group is listed, and the record does not report detailed analysis methods, missing-data procedures, or a multiplicity strategy.