Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (NCT05293639), a na na study. The primary outcome is Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs).

2. Clinical Question

This design addresses a safety question in people who received the study procedure, rather than a comparative question about outcomes under alternative treatments. The registered primary measure is the number of participants experiencing at least one event from a specified list, including stroke/CVA, major vascular access complication or bleeding, myocardial infarction, transient ischemic attack, pericarditis, pulmonary edema, heart block and other listed events. The registry defines an adverse event as an untoward medical occurrence that does not necessarily have a causal relationship with the intervention.

The record also identifies change from baseline in the Atrial Fibrillation Effect on Quality-of-Life Questionnaire total score as a secondary outcome. It names the pivotal main phase per-protocol analysis set and the pilot safety and pivotal roll-in analysis sets for those assessments. Results for these quality-of-life outcomes are not reported in the registry record. Thus, the stated clinical objective is broader than the outcome detail available in the posted results.

3. Trial Design

AdmIRE is registered as a completed, single-group study with enrollment of 362. The listed intervention is device-based pulse field ablation, described as using a circular multi-electrode pulsed electrical field catheter and a multichannel generator. The study objective specifies pulmonary vein isolation using the VARIPULSE™ Catheter with the TRUPULSE™ Generator in people with symptomatic paroxysmal atrial fibrillation.

The allocation field is NA and masking is listed as NONE. No randomized control group is described. The pilot safety analysis set, pivotal roll-in analysis set and pivotal main safety analysis set are phases or analysis populations reported within the study; their counts should not be interpreted as a randomized comparison. Differences among these groups can reflect their distinct phase definitions and membership, rather than treatment effects.

The primary endpoint is a count of participants with primary adverse events in the pilot safety and pivotal roll-in analysis sets. The observation window is from Day 0 to Day 7 after catheter insertion on Day 0. The registry’s description of the pilot set includes participants enrolled in that phase who had study-catheter insertion, with or without PFA delivery. The roll-in description says participants had catheter insertion and undergone PFA delivery, but the remaining population description is incomplete in the registry record.

The record lists the study as completed, with a start date of 2022-04-18 and primary completion on 2023-12-11. It identifies the phase as NA. The registry does not report a randomized allocation scheme, masking procedures, or a detailed statistical analysis plan. Although the study objective refers to 12-month effectiveness, the outcomes excerpted in the record does not provide a numerical effectiveness result or a description of its analysis.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: mITT analysis set included all participants enrolled in the pivotal main phase who met eligibility criteria and had insertion of the study catheter. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

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 Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs), measured over From Day 0 to Day 7 post catheter insertion on Day 0.

The primary endpoint is the number of participants with primary adverse events (PAEs) during the period from Day 0 to Day 7 after catheter insertion on Day 0. It applies to the pilot safety analysis set and the pivotal roll-in analysis set. The endpoint is a participant count: it is intended to represent whether participants in those sets experienced a qualifying event during the stated window, not the total number of separate events.

The listed PAEs include permanent phrenic nerve paralysis, stroke/CVA, major vascular access complication or bleeding, thromboembolism, myocardial infarction, transient ischemic attack, pericarditis, pulmonary edema or respiratory insufficiency, heart block, and vagal nerve injury or gastroparesis. The registry’s general adverse-event definition makes clear that an event does not necessarily have a causal relationship with the study intervention. A count under this endpoint therefore records qualifying events observed in the specified population and window; it does not by itself establish causation.

General statistical context: a prespecified safety endpoint can focus attention on events considered important to monitor, while a fixed observation window makes the period of assessment explicit. The usefulness of the count for interpretation depends on knowing who was assessed, how events were defined and how completely they were collected. The registry record does not report a numeric result for this primary endpoint, a confidence interval, or further details about event adjudication. It also does not give the endpoint’s result for the pivotal main safety analysis set.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary endpoint is a count of participants with at least one event meeting the PAE definition. This differs from a count of all event occurrences: a participant with multiple qualifying events may still contribute as a participant with an event, depending on the endpoint’s participant-level definition. The registry labels the measure as a count of participants, rather than a rate or time-to-event outcome. The primary endpoint’s numerical result is not reported in the registry record.

General statistical context: a count is easiest to interpret alongside the number of people assessed and a clear event definition. A count alone does not express uncertainty, and it cannot be compared fairly with a count from a differently sized population. The posted serious and other adverse-event figures include participants at risk for each analysis set, but the primary PAE count is not given. The listed event rates also lack a reported denominator in the registry record.

Why is the single-group design important?

The study model is single group, allocation is NA and masking is NONE. This means the registered design does not provide a randomized control group for a treatment contrast. The pilot, roll-in and main safety populations are separate analysis sets, not comparator arms. Their counts describe events in those sets; differences between their counts do not estimate a randomized treatment effect.

General statistical context: an uncontrolled study can describe outcomes observed after an intervention, but comparison with an alternative requires additional assumptions or a suitable control group. Patient characteristics, event ascertainment, follow-up and phase-specific procedures can all affect observed counts. The registry record does not report an adjusted comparative analysis. It also does not report an analysis plan that would support a causal interpretation.

How should precision be assessed?

No confidence intervals for the primary endpoint or the broad safety counts are reported in the registry record. General statistical context: a confidence interval gives a range of values compatible with the data and the method’s assumptions. Its width conveys precision, while its placement can help readers assess the scale of uncertainty. An interval does not correct limitations in study design or establish causality.

Because the PAE result and its interval are absent, the precision of the main registered safety endpoint cannot be evaluated from this record. The event counts and at-risk counts are descriptive information, not a substitute for an interval. The reported serious-event terms and percentages also should not be used to derive precision because their denominators and calculation details are not stated.

What role does the planning illustration play?

The study record’s sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event outcomes, the assumptions specify total events; for other outcomes, they specify participants per arm. These are assumptions for planning illustrations, not a description of the registered single-group design.

General statistical context: sample-size planning asks what amount of information a future design might require under selected assumptions. It is not an estimate of the probability that a completed study’s findings are correct, and it is not observed power. Equal allocation between two arms does not match the registered single-group model. The registry record does not report that these assumptions formed the sponsor’s own design justification, nor does it report a sample-size justification or interim analyses.

What can be concluded from the posted analysis detail?

The record lists six outcome measures and zero analyses. That means the record does not provide analysis entries for the outcomes in the information available. It does not establish that no analyses were conducted; it establishes that analysis details are not reported in the registry record. No statistical model, covariate adjustment, hypothesis-testing procedure or interval-estimation method for the primary endpoint is reported there.

General statistical context: a prespecified analysis plan helps readers distinguish planned outcome definitions and methods from choices made after results are known. Missing analysis detail makes it harder to judge how missing observations were handled, whether all eligible participants were included, or how multiple outcomes were addressed. Those uncertainties should be kept separate from the observed descriptive counts. The record’s counts remain informative as recorded observations, but they do not provide the missing statistical detail or support broader comparative claims.

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("Pilot Safety Analysis Set", "Pivotal Roll-In Analysis Set")
n      <- c(20, 63)
events <- c(0, 0)
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  Pilot Safety Analysis Set  20  0  0.0  0.0  16.8  0.0  16.1  0.1  16.1
ARM  Pivotal Roll-In Analysis Set  63  0  0.0  0.0  5.7  0.0  5.7  0.0  5.6

11. Multiplicity, Missing Data and Analysis Populations

The record lists six outcome measures and zero analyses. It identifies the primary safety endpoint and secondary AFEQT change-from-baseline outcomes, but does not report a full statistical analysis plan, an approach to multiplicity, or a hierarchy for interpreting secondary outcomes. The registry record does not report whether interim analyses were planned or conducted. Without those details, it is not possible to determine how the study accounted for the chance of false-positive findings across multiple outcomes or analyses.

Missing-data handling is not reported in the registry record. The record does not state how participants with incomplete follow-up, unavailable questionnaire scores or missing event assessments were handled. Nor does it describe imputation, sensitivity analyses, or rules for excluding participants from particular analyses. The stated analysis populations indicate phase-specific sets, but detailed inclusion and exclusion rules are not reported; the roll-in population description is also incomplete.

These omissions matter because denominators and analysis populations determine the interpretation of outcome counts and changes from baseline. General statistical context: missing outcome information can affect both the estimate and its uncertainty, particularly if missingness is related to participant status or study events. A named analysis set does not by itself explain how missing observations within that set were treated. The posted record therefore supports a description of the recorded counts, but not a judgment about the robustness of the results to missing data or multiplicity.

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: urinary tract infection (4.8%), syncope (4.8%), atrial flutter (1.6%), sinus arrest (1.6%), sudden cardiac death (1.6%).

The registry lists serious and other adverse-event figures separately for the Pilot Safety Analysis Set, Pivotal Roll-In Analysis Set and Pivotal Main Safety Analysis Set. Serious-event counts are 2 of 21, 7 of 64 and 31 of 277, respectively; other-event counts are 12 of 21, 23 of 64 and 109 of 277. These figures describe participants with events in each analysis set. They are not randomized group comparisons.

The term-specific serious adverse-event rates are listed as Urinary tract infection at 4.8%, Syncope at 4.8%, and Atrial flutter, Sinus arrest, Sudden cardiac death and Anaphylactic reaction at 1.6% each. The record does not report the denominators or further calculation details for these rates. They should not be assumed to use the same denominator as any particular analysis set.

The primary endpoint is not interchangeable with the broad serious-event figures. It concerns specified PAEs in the pilot and roll-in sets over the period from Day 0 to Day 7 after catheter insertion on Day 0; its numeric result is not reported in the registry record. The record’s general definition also notes that an adverse event does not necessarily have a causal relationship with the intervention. These counts document reported events but, on their own, do not establish causation or comparative safety.

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

The record documents a completed, single-group study of pulsed field ablation and describes its aim as assessing safety and 12-month effectiveness in symptomatic paroxysmal atrial fibrillation. The posted safety information gives counts of participants with serious and other adverse events in three analysis sets, together with a list of serious-event terms and rates. This provides a descriptive account of recorded safety events in the reported populations.

The primary registered endpoint is a participant count for specified adverse events from Day 0 to Day 7 after catheter insertion. Its result is not reported in the registry record. The broad serious-event counts do not substitute for that endpoint, because the record does not establish that they use the same event definition and time window. The results for the AFEQT quality-of-life outcomes and numerical 12-month effectiveness outcomes are also not reported in the registry record.

The study has no registered randomized comparator. Consequently, the observed event counts cannot show how safety or effectiveness would compare with another treatment. Differences between pilot, roll-in and main safety sets do not constitute evidence of a treatment difference: the sets are not like-for-like randomized arms. The record also does not report confidence intervals or detailed analysis methods that would allow a fuller assessment of precision.

General statistical context: observed outcomes in a clinical study are evidence about what was recorded among the participants assessed under that study’s conditions. Interpreting them beyond that setting requires attention to selection, measurement, follow-up and study design. The registry record does not provide enough detail to assess all of those issues. The information supports a cautious description of the listed safety observations, but it does not establish a causal treatment effect or resolve the stated effectiveness question.

14. Why This Trial Matters Statistically

This study is statistically notable because its objectives cover both safety and 12-month effectiveness, while the primary endpoint is a short-window safety count from Day 0 to Day 7 after catheter insertion. Those outcomes address different questions and have different observation windows. Keeping them distinct prevents broad adverse-event summaries from being mistaken for the registered primary endpoint or for a long-term effectiveness result.

The single-group design also determines what the data can answer. The record includes counts from pilot, roll-in and main safety analysis sets, but none is a randomized control group. The counts can describe events recorded within each set; they cannot isolate the effect of the procedure by comparing treated participants with a concurrent randomized control group. The allocation and masking fields further underscore that no randomized, masked comparison is described.

The outcome reporting raises practical questions for statistical interpretation. The primary PAE result, AFEQT results and numerical effectiveness results are not reported in the registry record. The record lists zero analyses and does not describe confidence intervals, missing-data procedures, multiplicity handling or a detailed statistical plan. These absences limit assessment of both precision and analytic robustness.

General statistical context: trial design, endpoint definition, analysis population and reporting completeness jointly shape the strength of an inference. A descriptive event count can be useful without being a comparative effect estimate. This record therefore illustrates why readers should identify exactly which outcome, population and time window a safety figure represents before drawing conclusions from it.

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 registry record does not report the numeric result for the primary PAE endpoint, despite defining its event list, analysis sets and observation window. It also does not report numerical results for the named AFEQT secondary outcomes or the stated 12-month effectiveness objective. The serious and other adverse-event figures are available, but they are not identified as the primary endpoint result.

The single-group design has no registered randomized comparator, so the event counts do not estimate a randomized between-group effect. The three safety analysis sets are not like-for-like control and treatment groups. Masking is listed as NONE, and the record does not provide further detail about event adjudication or assessment procedures. The relationship between the listed term-specific rates and their underlying denominators is not reported.

Analysis details are limited: the record lists zero analyses and does not report confidence intervals, missing-data methods, multiplicity procedures, interim analyses or a detailed statistical analysis plan. The pilot population description is available, while the pivotal roll-in description is truncated. Further eligibility and analysis-set rules are not reported in the registry record. These limitations restrict assessment of endpoint precision, completeness of follow-up and the comparability of the phase-specific populations. They also prevent conclusions about causal effects or the robustness of the posted safety summaries.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System — NCT05293639.
• Registry record last updated 2025-05-25; status last verified 2025-05.
• Results first posted 2025-04-04.
• 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

AdmIRE (NCT05293639) is a completed, single-group device study sponsored by Biosense Webster, Inc. It concerns pulse field ablation for pulmonary vein isolation in symptomatic paroxysmal atrial fibrillation. Enrollment is listed as 362; the start date is 2022-04-18 and primary completion is 2023-12-11. The phase is listed as NA, allocation as NA and masking as NONE.

The primary endpoint counts participants with specified PAEs in the pilot safety and pivotal roll-in analysis sets from Day 0 to Day 7 after catheter insertion on Day 0. The registry lists serious and other adverse-event counts for the pilot, roll-in and pivotal main safety sets. It does not report the numeric primary endpoint result, numerical AFEQT results or numerical effectiveness results. The record lists six outcome measures and zero analyses, with no detailed statistical plan or missing-data procedure reported.