Amplatzer Amulet China Post Market Study (PMS): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Amplatzer Amulet China Post Market Study (PMS) (NCT06189365), a registered phase not stated study. The primary outcome is Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events.

2. Clinical Question

3. Trial Design

NCT06189365 is titled the Amplatzer Amulet China Post Market Study (PMS) and lists Abbott Medical Devices as its sponsor. The registry record describes a prospective evaluation of the safety and effectiveness of the Amplatzer Amulet left atrial appendage occluder in a Chinese patient population with non-valvular atrial fibrillation. The listed intervention is a left atrial appendage closure procedure using that device.

The record lists an enrollment of 50 and one intervention arm, titled Amulet Left Atrial Appendage Occluder. It does not identify a comparator arm. The registry characterizes the study as not being a randomized comparison, while allocation is not stated. These details do not support a like-for-like comparison between treatment groups.

The recorded study start date is 2024-01-30, and the primary completion date is 2025-12-05. The status is TERMINATED. The reason for termination, whether the planned enrollment was completed, and the number of participants who received the device are not reported in the registry record. The safety summary lists 50 participants at risk, but the number analyzed for the primary endpoint is not stated.

The primary endpoint is a count of participants with one or more specified major adverse events within 7 days after the procedure. The registry record lists seven outcome measures and no analyses. It does not report primary endpoint results, statistical estimates, or a statistical analysis plan. Details about other outcome definitions and their results 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

Analysis population for the primary outcome, as defined in the registry: The number of participants analyzed includes subjects with Amulet occluder implanted.

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 Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events, measured over 7 days.

The primary endpoint counts participants who experience one or more major adverse events within 7 days after the procedure. The listed events are all-cause mortality; procedure- or device-related complications requiring open cardiac surgery or major endovascular intervention; ischemic or hemorrhagic stroke; and systemic embolism. The population definition says that participants analyzed include subjects with an Amulet occluder implanted.

A combined endpoint can capture several serious outcomes in a single measure. This can be useful when the clinical question concerns a broad category of short-term safety events rather than any one event alone. The combined result, however, would not by itself show which component occurred or how often each component occurred. Component-specific results are not reported in the registry record.

The registry specifies the endpoint and its time window but does not report the number of participants meeting it. It also does not report an estimate of uncertainty or a comparison with another group. Consequently, the endpoint definition explains what the study intended to count, but it does not establish the observed short-term event frequency.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count mean?

The primary outcome is a binary participant-level endpoint: each participant is classified according to whether one or more qualifying events occurred within the specified time window. The registry describes the result type as a count of participants with an event. This differs from a count of all events, because a participant with multiple qualifying events may still contribute as a participant meeting the combined endpoint. The record does not report the observed participant count for this endpoint.

For a binary outcome, analysts commonly report the number meeting the endpoint and the number included in the analysis. A proportion can then describe the observed frequency in that study population. An uncertainty interval, such as a confidence interval, communicates how imprecise an estimate may be under the statistical model. In general, a confidence interval is not a guarantee that the true value lies within its limits; it is a way to express uncertainty in an estimate. No endpoint estimate or confidence interval is reported in the registry record, so neither the frequency nor its precision can be assessed.

Why does the analysis population matter?

The endpoint description says that the analyzed population includes subjects with the Amulet occluder implanted. This is an important qualification: the endpoint is not described as applying automatically to every person enrolled. To interpret a participant count, readers need to know who was eligible for analysis, how many participants entered that population, and how missing outcome information was handled. The record does not state the number analyzed for the primary endpoint or provide details about missing endpoint observations.

The adverse-event summary lists 50 participants at risk, while the study enrollment is listed as 50. The registry does not establish that these are the same population as the primary endpoint analysis population. A denominator should be interpreted alongside its stated population and endpoint; counts from different summaries should not be assumed to share the same definition or follow-up period.

What can a single-arm study estimate?

With no comparator arm identified, the listed study can describe outcomes observed among participants receiving the device and procedure, if those outcomes are reported. A comparison with an external or historical group would require additional information and assumptions; no such comparison is described in the registry record. The record also states that the study is not a randomized comparison and that allocation is not stated. It therefore does not support attributing differences between groups to treatment, because no randomized treatment contrast is reported.

Even in a comparative study, randomization is used to help balance factors that may affect outcomes. In a non-comparative study, observed event frequencies can still be useful for describing the participants and safety experience, but interpretation depends on the study population, event definitions, follow-up, and completeness of outcome ascertainment. Details about these features beyond the endpoint definition are not reported in the registry record.

Why are event definitions and follow-up important?

The primary endpoint combines all-cause mortality, specified serious procedure- or device-related complications, stroke, and systemic embolism within 7 days after the procedure. The time window and qualifying events define what the count represents. A change in event definition or follow-up window would change the meaning of the result, so counts should be interpreted only in relation to the stated definition. The registry does not report component-specific primary endpoint counts.

Combining outcomes can make a broad safety measure easier to summarize, but the components may differ in frequency and clinical meaning. A combined result alone would not reveal which components drove it. For that reason, component-level reporting can complement the overall endpoint. Such component-level primary endpoint results are not reported in the registry record.

What is not available for statistical assessment?

The registry lists seven outcome measures and zero analyses. It does not report a statistical analysis plan, hypothesis tests, confidence intervals, adjusted estimates, interim analyses, or missing-data procedures. These methods should not be inferred from the endpoint definition or from the fact that the study was prospective. Without a reported analysis, no p-value or precision assessment can be interpreted for the primary endpoint.

General statistical practice distinguishes a prespecified analysis from an exploratory one because analysis choices can affect estimates and their interpretation. A prespecified plan may define the analysis population, treatment of incomplete follow-up, and methods for uncertainty estimation before results are reviewed. Whether such a plan existed for this study is not reported in the registry record. The registry status of TERMINATED also does not, by itself, establish which analyses were completed or why the study ended.

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("Amulet Left Atrial Appendage Occluder")
n      <- c(47)
events <- c(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  Amulet Left Atrial Appendage Occluder  47  0  0.0  0.0  7.5  0.0  7.6  0.1  7.4

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists seven outcome measures but no analyses. It identifies the primary short-term safety endpoint, but does not report results for that endpoint or describe how the other outcome measures were analyzed. A multiplicity strategy is not reported in the registry record.

Multiplicity is a general statistical concern when several outcomes or comparisons are tested. As the number of tests grows, the chance of obtaining at least one apparently notable result by chance can increase. Statistical plans sometimes address this by prioritizing outcomes, adjusting inference, or distinguishing confirmatory questions from exploratory ones. The record does not say whether any such approach was planned or used. No adjustment should be assumed.

Missing-data methods are also not reported. The endpoint population is described as including subjects with the device implanted, but the number analyzed for the primary endpoint and the amount of missing endpoint information are not stated. In general, incomplete follow-up can affect an event count if participants with unknown outcomes are handled differently from participants known to have completed assessment. The registry record does not describe follow-up completeness, imputation, censoring, or other missing-data procedures.

The record does not report an analysis population beyond the endpoint description, nor does it explain whether the safety-summary population differs from the primary endpoint population. Those distinctions matter because the denominator determines what a participant count represents. Without the analysis details and endpoint results, readers cannot assess the impact of missing data or multiplicity on statistical inference.

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 (4.0%), congestive heart failure (4.0%), pericarditis (2.0%), gastrointestinal bleeding (2.0%), incarcerated inguinal hernia (2.0%).

The adverse-event summary lists 10 participants at risk with serious adverse events and 8 participants at risk with other adverse events in the Amulet Left Atrial Appendage Occluder group. It lists 1 death. These figures describe the registry’s safety summary; they are not the reported result of the defined primary endpoint. The registry does not specify in this summary whether the events use the primary endpoint’s 7-day window or its event definitions.

The record lists serious adverse-event terms with the following percentages: Atrial Fibrillation, 4.0%; Congestive Heart Failure, 4.0%; Pericarditis, 2.0%; Gastrointestinal Bleeding, 2.0%; Incarcerated Inguinal Hernia, 2.0%; and False Aneurysm, 2.0%. These are terms in the adverse-event summary, not the component-specific results for the primary endpoint. The record does not explain whether participants could contribute more than one term, so the percentages should not be added or interpreted as mutually exclusive categories.

The registry does not report further detail about event timing, duration, seriousness criteria, relatedness to the device or procedure, or outcomes of the events in this summary. The figures can be read as posted safety information, but they do not establish causation or provide a comparison with another group.

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

The study was intended to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet left atrial appendage occluder in a Chinese patient population. Its stated primary endpoint focuses on major adverse events within 7 days after the procedure. The registry record defines that endpoint, but does not report its result. As a result, the posted record does not show how many participants met the primary endpoint or how precisely that outcome was estimated.

The safety summary does contain counts for serious adverse events, other adverse events, and deaths, as well as percentages for listed serious-event terms. These figures can be described as part of the posted safety information. They cannot be treated as the primary endpoint result because the registry does not establish that the definitions, population, or follow-up window match. Nor do these figures establish that the device or procedure caused the events.

The record identifies no comparator arm and states that this is not a randomized comparison. The study information therefore does not show whether outcomes differ from those under another treatment or approach. It also does not support a comparative conclusion about effectiveness. The study’s broad purpose includes effectiveness, but specific effectiveness results are not reported in the registry record.

The status is TERMINATED. The reason for termination, the extent of follow-up, and the relationship between termination and the available safety data are not reported. The enrollment listing and the safety summary do not resolve those questions. In general, a study status is context for interpreting a record, not a substitute for endpoint results or an explanation of why data are unavailable.

The appropriate reading is therefore limited: the registry states what the study set out to evaluate, defines a short-term safety endpoint, and includes selected safety counts. It does not provide enough reported analysis to determine the primary endpoint outcome, estimate its precision, or make comparative claims.

14. Why This Trial Matters Statistically

Post-market studies can add information about device use in a population and setting identified in the registry record. This study’s stated focus is a Chinese patient population with non-valvular atrial fibrillation, and its primary question concerns specified major adverse events within 7 days after the procedure. The endpoint definition makes the intended safety question explicit, which is a useful starting point for interpreting a clinical study.

The record also illustrates why a clear endpoint definition and an analyzed result are both needed. Naming the events and time window tells readers what the study intended to measure, but without the observed count and an analysis, it is not possible to assess the result or its precision. The listed safety-summary counts offer some descriptive information, yet they do not replace the primary endpoint result when their relationship to that endpoint is not specified.

Design context matters as well. The record identifies no comparator and says the study is not a randomized comparison. Those features limit the kinds of statistical conclusions that can be drawn: descriptive safety information is distinct from evidence of a comparative effect. Reporting the analysis population, follow-up, and uncertainty would help readers judge how much weight to place on an observed event frequency.

The record’s TERMINATED status makes transparent reporting of endpoint results and the reason for termination particularly relevant. Neither the reason nor the primary endpoint analysis is reported. The statistical importance of this study record is therefore less about a demonstrated treatment effect and more about recognizing what the registry does and does not document for a post-market safety 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 most direct limitation is that the registry record does not report the primary endpoint result. Although the endpoint is defined and the record lists an enrollment of 50, it does not state the number meeting the endpoint, the number analyzed for it, or an estimate of uncertainty. The adverse-event summary cannot fill this gap because its relationship to the primary endpoint’s population, definitions, and 7-day time window is not stated.

No comparator arm is identified, and the record says the study is not a randomized comparison. Allocation is not stated. The study information therefore does not support a like-for-like control comparison or a comparative treatment-effect estimate. The registry does not report a statistical analysis plan, sample-size justification, interim analyses, or a method for handling missing data.

The registry lists seven outcome measures but no analyses. Results for outcomes other than the defined primary endpoint are not described in the information reported. Details on participant eligibility, baseline characteristics, follow-up completeness, and the number who received the device are not reported in the registry record. These omissions make it difficult to assess who contributed to each summary and how representative the observed safety information may be.

The status is TERMINATED, but the reason for termination and any effect on enrollment or follow-up are not reported. The listed safety figures include serious adverse events, other adverse events, and deaths, but further details about timing, relatedness, and event handling are not given. These limitations constrain interpretation of both the primary safety question and the broader stated aim of evaluating effectiveness.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Amplatzer Amulet China Post Market Study (PMS) — NCT06189365.
• Registry record last updated 2026-08-13; status last verified 2026-07.
• Results first posted 2026-07-02.
• 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

NCT06189365 is the Amplatzer Amulet China Post Market Study (PMS), sponsored by Abbott Medical Devices. The registry describes a prospective evaluation of the Amplatzer Amulet left atrial appendage occluder in a Chinese patient population with non-valvular atrial fibrillation. The listed enrollment is 50, and the study status is TERMINATED. The recorded start date is 2024-01-30, with primary completion dated 2025-12-05.

The defined primary endpoint is the count of participants with one or more specified major adverse events within 7 days after the procedure. No result or analysis for that endpoint is reported in the registry record. The safety summary lists 10 participants at risk with serious adverse events, 8 with other adverse events, and 1 death. No comparator is identified, and the record states that this is not a randomized comparison. The reason for termination and the statistical analysis plan are not reported.