A RWS of the FARAPULSE in A Chinese Population With PAF: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A RWS of the FARAPULSE in A Chinese Population With PAF (NCT05493852), a registered phase not stated study. The primary outcome is Number of Participants With Acute Procedural Success.

2. Clinical Question

3. Trial Design

The registry describes a real-world, single-center, single-arm observational study of the FARAPULSE Pulsed Field Ablation System in a Chinese population with paroxysmal atrial fibrillation. Its summary characterizes the study as retrospective and/or prospective; the record does not specify which approach was used. The study status is completed. The listed study start date is 2023-02-24, and the primary completion date is 2023-08-21.

Enrollment was 30. The population description focuses on patients with paroxysmal atrial fibrillation and an indication for ablation; the summary further describes recurrent, symptomatic disease. The registry record does not report additional eligibility criteria or detailed baseline characteristics. It also does not provide a separate description of how participants were identified or followed.

The intervention was the FARAPULSE Pulsed Field Ablation System. There is no comparator arm described, and the study is not a randomized comparison. Accordingly, its design can describe procedural outcomes and reported events in the study population, but does not provide a controlled estimate of the difference between FARAPULSE and another treatment. The record does not report allocation procedures beyond the single-arm description.

Two outcome measures are listed. The primary effectiveness measure is acute procedural success on Day 0, defined by electrical isolation of all pulmonary veins using FARAPULSE alone. Although the endpoint definition is present, its result is not reported in the registry record. The record lists no analyses. Details of the study protocol, monitoring schedule beyond the stated endpoint timeframe, and the analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

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

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Acute Procedural Success, measured over Day 0.

The primary endpoint is the number of participants with acute procedural success, with the registry describing the measure as a count of participants and specifying Day 0 as its timeframe. Success is defined as achieving electrical isolation of all pulmonary veins using the FARAPULSE Pulsed Field Ablation System only. The definition ties the endpoint to an immediate procedural outcome rather than a later clinical event.

Such an endpoint can summarize whether the intended electrical isolation was achieved during the procedure. A count is useful for describing how many participants met the stated criterion; a proportion additionally expresses that count relative to an eligible denominator. The registry record gives the endpoint definition but does not report the observed success count, a proportion, or a confidence interval. The listed enrollment of 30 does not by itself establish how many participants had an evaluable endpoint.

Acute procedural success is not equivalent to longer-term control of atrial fibrillation or freedom from later procedures. The endpoint description does not define a follow-up assessment of those outcomes. Nor does the endpoint definition alone establish whether an observed success is attributable to the device rather than other aspects of care. With no comparator and no reported endpoint result, the record identifies what was intended to be measured but does not quantify the observed procedural success.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry defines the primary effectiveness outcome as a binary participant-level event: a participant either meets the specified criterion for acute procedural success or does not. The criterion is electrical isolation of all pulmonary veins using the FARAPULSE Pulsed Field Ablation System only, assessed on Day 0. The outcome is described as a count of participants. A count communicates the number meeting the definition; a proportion places that count in relation to the participants assessed.

For a binary outcome, a confidence interval is a way to express uncertainty around an estimated event proportion. In general, the interval reflects both the observed result and the amount of information available; it is not a guarantee that the true value lies within its limits. Its width is important: a point estimate alone does not communicate precision. The registry record does not report the acute-success count, proportion, or confidence interval, so the size and precision of that result cannot be evaluated from the record.

Estimating a proportion also requires clarity about the denominator. Enrollment identifies the number enrolled, but it does not necessarily establish how many were assessed for a particular outcome. A reader would need the endpoint-evaluable population and an account of any participants without an assessment to interpret a reported proportion. The registry record does not report these details for acute procedural success. No missing-data approach or endpoint analysis population is described.

The study is observational and single-arm. Descriptive summaries can characterize outcomes among the participants in that arm, but a treatment comparison requires a suitable comparator. In a randomized study, random allocation is intended to balance measured and unmeasured factors on average; this design does not have that feature. General statistical adjustment cannot be assumed to remove all differences or confounding, and the registry record lists no adjusted analysis. It also lists no analyses at all.

There are two outcome measures in the record, but only the primary effectiveness endpoint is described in the available information. When multiple outcomes or repeated statistical tests are analyzed, multiplicity can increase the chance of a false-positive finding if no strategy is specified. A multiplicity approach might prioritize a primary outcome, adjust significance thresholds, or treat secondary outcomes as exploratory. The registry record does not report a multiplicity strategy, and it does not provide enough detail to determine what analyses were planned or performed.

The sample-size assumptions associated with planning illustrations are not a description of the study's own design or evidence of observed power. The stated assumptions for those illustrations include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of an observed effect. For time-to-event illustrations, the stated convention is a total number of events; for other illustrations, it is participants per arm. These are planning assumptions, not reported design features of this single-arm observational study. The record does not report a sample-size justification for the trial itself. In general, a planning calculation estimates the sample needed to target a specified precision or probability of detecting an assumed effect; it does not measure the probability that an already completed study's result is correct.

For binary outcomes, a normal approximation can be used in some planning or estimation settings. Its adequacy depends on the data and the calculation; the stated planning assumption does not establish that this approximation was used for the trial's analysis. The registry record does not identify an inferential procedure for the primary endpoint. It would be inappropriate to infer a test, model, adjustment, or confidence-interval method from the endpoint type alone.

Over-dispersion is a general concern when observed variation is greater than a model assumes. For example, outcomes may be more alike within centers or clusters than a model treating observations as independent would expect. Accounting for such dependence can affect standard errors and uncertainty. This trial is described as single-center, but the registry record does not report a model or a method for addressing dependence; no claim about over-dispersion or its handling can be made.

Finally, a result's interpretation depends on the endpoint definition, the analysis population, missing-data handling, and uncertainty—not only on the event count. These elements are not fully documented for the primary endpoint in the registry record. The primary question is clear as a definition, but a numerical effectiveness estimate and its statistical interpretation are not available from the registry information.

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("FARAPULSE Pulsed Field Ablation System")
n      <- c(30)
events <- c(30)
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  FARAPULSE Pulsed Field Ablation System  30  30  100.0  88.4  100.0  88.6  100.0  88.8  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures but provides no multiplicity strategy. When a study evaluates multiple endpoints or performs multiple tests, the chance of a false-positive result can increase if each test is interpreted without regard to the others. A prespecified hierarchy, adjustment method, or explicit exploratory interpretation can clarify how findings are to be read. None is reported in the registry record. Because no analyses are listed, it is also not possible to determine whether any multiplicity procedure was applied.

The registry record does not report missing-data methods. It does not state how participants with an unavailable or unevaluable endpoint would be handled, whether any such cases occurred, or whether sensitivity analyses were planned. These details matter because excluding participants with missing outcomes can affect the denominator and may bias a result when missingness is related to outcome or participant characteristics. The enrollment of 30 does not establish the number with a recorded primary endpoint.

No analysis population is specified for the primary effectiveness endpoint. The record does not say whether the endpoint was assessed among all enrolled participants, only those who underwent the procedure, or another defined group. It also does not identify an intention-to-treat or per-protocol analysis. These labels should not be inferred from the single-arm design.

As a result, the record does not permit assessment of how missing observations, analysis-population choices, or multiple outcomes affected any statistical finding. These are reporting gaps, not evidence that missing data or multiplicity problems occurred.

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: atrial fibrillation (10.0%), pneumonia (3.3%).

The registry reports serious adverse events in 4 participants at risk of 30 in the FARAPULSE arm. It reports other adverse events in 20 participants at risk of 30, and 0 deaths. These are participant counts, not a comparison of event rates between treatment groups. The study has no comparator arm, and the record does not establish whether each event was judged related to the device or procedure.

The leading serious-event terms listed are atrial fibrillation at 10.0% and pneumonia at 3.3%. These percentages are reported as terms in the registry record; detailed definitions, timing, severity beyond the serious-event classification, and attribution are not reported. The terms should not be read as a complete account of all clinical events or as proof of a causal relationship.

Serious adverse events and other adverse events are separate reported categories. A participant-level count does not necessarily describe the total number of events, since a participant may experience more than one event. The registry record does not provide event-level narratives or additional detail needed to resolve that distinction. These figures describe what is posted for this arm and do not establish comparative safety.

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

The registry record establishes that a completed, single-center observational study enrolled 30 participants and specified acute procedural success as its primary effectiveness endpoint. The endpoint was defined as electrical isolation of all pulmonary veins using FARAPULSE alone on Day 0. The record also reports serious and other adverse-event counts, including 0 deaths. These registry entries describe the scope and selected outcomes recorded for the study.

The record does not report the primary success count or proportion. It therefore cannot quantify the observed acute procedural success, indicate how precise an estimate would be, or support a conclusion about the frequency of success in the study population. The endpoint definition is not itself a result. Similarly, enrollment is not an outcome denominator unless the record establishes that all enrolled participants were assessed.

The safety counts do not show that the device caused the listed events. They are not a comparison with another treatment, and the study design offers no control group against which to interpret differences. The record does not provide detailed event attribution or timing. The adverse-event information should be read as descriptive reporting from the FARAPULSE arm rather than as a causal estimate.

More broadly, a single-arm observational study can describe what was recorded among the participants included, but it cannot isolate the effect of the intervention from other factors as a randomized comparison can. The registry record does not report an adjusted analysis, an analysis population, or methods for missing data. It also lists no statistical analyses. These omissions limit assessment of both the size and the reliability of any effectiveness estimate.

The study's stated purpose was to observe safety and effectiveness in a Chinese population with paroxysmal atrial fibrillation. That purpose is distinct from what can be concluded from the posted results. The available record supports a description of the study and its reported safety counts; it does not establish a treatment effect, a comparison with alternatives, or a precise estimate of acute procedural success.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between defining an outcome and reporting its result. The registry provides a specific acute procedural success definition, a participant count as the measure, and Day 0 as the timeframe. Yet it does not report the observed count or proportion. Without that result, readers cannot judge the level of success or its precision, even though the endpoint itself is clearly named.

The single-arm observational design also shapes the questions the data can answer. It can document outcomes recorded in the FARAPULSE arm, but it does not estimate a contrast with another intervention. This is important because a descriptive event rate and a treatment effect are different statistical quantities. The latter requires a comparison and assumptions about how treatment groups relate; this study does not provide a comparator group.

The posted adverse-event counts illustrate another distinction: counts of participants with events describe reported burden, but do not by themselves establish causation. The serious-event terms and death count are relevant descriptive information, while attribution, event timing, and comparative risk are not reported. Clear separation of event description from causal interpretation is central to sound statistical reading.

Finally, the record lists no analyses and does not describe the analysis population, missing-data approach, or multiplicity strategy. These omissions make it difficult to assess how an estimate would have been generated and what uncertainty or potential bias it might carry. The trial therefore highlights why endpoint definitions, denominators, analysis methods, and results all matter: each answers a different part of the statistical question.

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 principal limitation for interpreting effectiveness is that the primary endpoint result is not reported in the registry record. The definition is available, but there is no observed success count, proportion, or uncertainty estimate. The enrollment of 30 does not resolve this gap, because the number assessed for the endpoint is not specified.

The study is described as single-center and single-arm, with no randomized comparator. Any outcome is therefore descriptive for the study arm and cannot provide a direct treatment contrast. The registry record does not report participant characteristics beyond the paroxysmal atrial fibrillation population and the stated ablation indication, limiting assessment of how closely the study participants represent other populations.

The record characterizes the study as retrospective and/or prospective without specifying which. It does not report detailed eligibility criteria, follow-up procedures, or additional procedural methods. The primary outcome is an acute Day 0 measure; the record does not provide a longer-term effectiveness result in the registry record. The registry lists two outcome measures, but the other outcome is not described in detail.

Statistical limitations include no listed analyses and no reported analysis population, missing-data approach, or multiplicity strategy. The record also does not report a trial-specific sample-size justification. These gaps prevent assessment of the planned inferential framework and the handling of unavailable outcomes. The safety information lacks detailed event narratives and attribution, so causal interpretation is not supported.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A RWS of the FARAPULSE in A Chinese Population With PAF — NCT05493852.
• Registry record last updated 2025-01-31; status last verified 2025-01.
• Results first posted 2024-12-16.
• 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.

19. Record Summary

NCT05493852 is a completed, single-center, single-arm observational study of the FARAPULSE Pulsed Field Ablation System in a Chinese population with paroxysmal atrial fibrillation. The registry describes the study as retrospective and/or prospective and reports enrollment of 30. The listed start date is 2023-02-24, and the primary completion date is 2023-08-21.

The primary effectiveness endpoint is acute procedural success on Day 0, defined as electrical isolation of all pulmonary veins using FARAPULSE alone. Its observed result is not reported in the registry record. The record lists no analyses. It reports serious adverse events affecting 4 participants at risk of 30, other adverse events affecting 20 participants at risk of 30, and 0 deaths. Atrial fibrillation at 10.0% and pneumonia at 3.3% are listed among the leading serious-event terms. The single-arm design and missing primary result limit interpretation of effectiveness and comparative safety.