Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes (NCT05936996), a registered phase not stated study. The primary outcome is Rate of VARC-3 Major & Minor Vascular Complications.

2. Clinical Question

The registry’s objective is to collect outcomes associated with contemporary MANTA closure in standard-of-care TAVR procedures. Because the study is observational, its results describe outcomes among participants receiving the device under the stated clinical-use conditions. They do not by themselves establish what would have happened to comparable participants treated with another closure approach. No comparator is specified, and the record does not report a comparative analysis.

3. Trial Design

This is an observational clinical registry evaluating the MANTA Vascular Closure Device in TAVR procedures. The study description says that participants undergoing TAVR are enrolled and that the registry collects outcomes with on-label use in standard-of-care practice. The stated focus includes appropriate patient selection and proper vascular access. The registry lists Femoral Arteriotomy Closure as the condition and identifies Essential Medical, Inc. as the sponsor.

The registry lists an enrollment of 258 and a status of completed. The recorded study start is 2023-11-15, and primary completion is recorded as 2025-06-20. These registry fields describe the study record; they do not establish that every planned analysis was completed or that every outcome was reported. The record lists 10 outcome measures and 0 analyses.

No random assignment is described. Allocation is stated as not reported, and the registry’s own caution notes that the arms are not a like-for-like control comparison. The record does not identify a comparator arm or describe a randomized design. Accordingly, the study is best read as an outcomes registry rather than as a controlled estimate of the effect of MANTA relative to another device or approach.

The primary outcome is the percentage of participants with one or more VARC-3 major or minor vascular complications within 30 days following TAVR. Other listed outcomes include additional interventions at the large-bore access site to address complications, discharge readiness, technical success, ambulation success, treatment success, and procedure time. Their results are not reported in the registry record. The registry record also does not report a protocol-level sample-size justification, interim-analysis plan, or 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: This single-arm registry summarizes the ITT population, defined as participants with an attempt to use the MANTA device. The On-Label cohort was a predefined subset of the ITT population used for outcome analyses and is not shown as a separate Participant Flow group.

Overall Study

Reasons for not completing this period:

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: All subjects that had an attempt to use the MANTA device.

6. Primary Endpoint

The registry lists the primary outcome as Rate of VARC-3 Major & Minor Vascular Complications, measured over within 30 days of TAVR procedure.

The primary endpoint is the percentage of participants experiencing one or more VARC-3 major or minor vascular complications within 30 days after the TAVR procedure. It combines major and minor events into a participant-level outcome: a participant meeting either category is counted as having the endpoint. The registry says the definitions follow Valve Academic Research Consortium-3 criteria and that reported events were reviewed and classified as major or minor by the study clinical events committee.

This type of endpoint is used to describe the frequency of clinically important vascular complications in the period specified by the study. Combining the categories gives an overall measure of participants with a qualifying complication, but does not show the separate frequency or severity distribution of major and minor events unless those results are reported separately. The registry record does not report the primary-endpoint percentage, its confidence interval, or separate major and minor results.

General statistical interpretation: a percentage is a proportion expressed on a percentage scale, and its precision depends on both the observed proportion and the amount of available information. A confidence interval describes uncertainty around an estimate under the statistical method used; it is not a range containing a guaranteed proportion of individual outcomes. The registry specifies a 95% confidence interval for this endpoint, but the numerical interval is not reported in the registry record. Without the endpoint estimate and interval, the magnitude and precision of the primary result cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods information in the registry record is limited. It identifies the study as observational, defines the primary endpoint, specifies a 95% confidence interval, and lists outcome and adverse-event fields. It does not report a detailed statistical analysis plan, the method used to calculate the confidence interval, or numerical primary-endpoint results. The explanations below describe general statistical ideas and should not be taken as a statement that a particular unreported method was used.

What does an observational design imply?

In an observational study, participants receive care in the clinical setting being studied rather than being randomly assigned by the study to alternative treatments. An outcome frequency can describe what occurred in the recorded population. It does not, on its own, isolate the effect of a device from the influence of participant selection, clinical practice, access-site characteristics, or other factors. Random assignment can help balance measured and unmeasured factors between comparison groups, but no randomized allocation is reported for this registry.

The registry description places the MANTA device in a specific context: standard-of-care TAVR, on-label device use, appropriate patient selection, and proper vascular access. That context is important when interpreting how representative the results may be. The record does not report detailed eligibility criteria, participant characteristics, or how adherence to the described selection and access practices was assessed. Those details are not reported in the registry record.

What does the primary percentage represent?

The primary outcome is defined as the percentage of participants with one or more VARC-3 major or minor vascular complications within 30 days following the procedure. For a binary participant-level outcome, each participant is classified according to whether the defined event occurred during the stated follow-up period. The percentage would describe the observed proportion meeting that definition in the analyzed population. No numerical estimate is reported, so the proportion itself cannot be evaluated from the registry record.

The endpoint combines major and minor complications. A combined endpoint can summarize whether participants experienced any event in the defined categories, while leaving the individual categories and their severity distributions less visible. The registry says that the study clinical events committee reviewed reported events and classified them according to VARC-3 criteria. The record does not report adjudication procedures beyond that description, the number of events reviewed, or separate results by complication class.

How should a confidence interval be understood?

General explanation: a confidence interval expresses statistical uncertainty around an estimate under a specified method and its assumptions. A narrower interval indicates greater precision in the estimate under that method, while a wider interval indicates greater uncertainty. It does not describe the range of outcomes for individual participants and does not guarantee that a future study will produce a value inside the interval.

The registry names a 95% confidence interval for the primary endpoint, but neither the interval nor the point estimate is reported in the registry record. The interval method is also not stated. Therefore, its precision cannot be evaluated, and there is no basis for checking how the interval was calculated. Confidence intervals for the adverse-event terms are not reported either.

Why does over-dispersion matter?

General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It can arise when outcomes are more heterogeneous than the model assumes, such as when participants differ in underlying risk or when observations are clustered. If a model ignores over-dispersion, standard errors may be too small and confidence intervals may be too narrow. Appropriate handling depends on the outcome and model, and should be set out in the analysis plan.

The primary outcome is described as a participant-level percentage, but the registry record does not report a model-based analysis, any over-dispersion assessment, or a method for accounting for clustering. It is not appropriate to infer that over-dispersion was present or that a particular correction was required. Those details are not reported in the registry record.

What can planning calculations tell a reader?

General explanation: sample-size calculations estimate the amount of information that might be needed to detect a specified effect under stated assumptions. They are planning illustrations, not evidence that an observed result is reliable and not a measure of observed power. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It also distinguishes time-to-event planning, which uses total events, from other planning outputs, which use participants per arm.

Those assumptions do not establish the registry’s original design rationale. The study is observational, no like-for-like control comparison is reported, and the registry record does not report the sample-size justification used to plan the study. Any planning illustration based on an observed effect should be interpreted as hypothetical rather than as the trial’s prespecified design or as observed power. The record does not report numerical planning results.

What does the absence of posted analyses mean?

The registry lists 0 analyses. This is a statement about the analyses recorded in the registry, not proof that no analysis was ever conducted elsewhere. With no posted analysis results, readers cannot assess model choices, adjustment variables, subgroup methods, or sensitivity analyses. The numerical primary endpoint and its confidence interval are not reported, so neither the estimated frequency nor its statistical precision can be evaluated from this record.

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("MANTA Device")
n      <- c(258)
events <- c(19)
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  MANTA Device  258  19  7.4  4.5  11.3  4.8  11.2  4.8  11.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary vascular-complication endpoint and secondary outcomes such as additional interventions at the large-bore access site, discharge readiness, technical success, ambulation success, treatment success, and procedure time. It does not report a multiplicity strategy, such as a hierarchy of confirmatory outcomes or an adjustment for multiple statistical tests. The record also lists 0 analyses, so no outcome-specific analysis results or testing procedures are reported.

General explanation: when many outcomes or comparisons are examined, the chance of obtaining at least one apparently notable result by chance can increase. A prespecified hierarchy or multiplicity adjustment can address that issue, depending on the study’s aims. Without a reported analysis plan or results, it is not possible to determine whether multiplicity was considered or how it might affect interpretation. The absence of a reported strategy should not be replaced by an assumption about what the investigators did.

The registry record does not report how missing outcome data were handled, whether follow-up was complete, or how participants with unavailable endpoint information were treated in the primary analysis. It also does not describe imputation, censoring, or sensitivity analyses for missingness. The endpoint’s 30-day timeframe is stated, but the record does not report participant-level follow-up completeness for that period. The listed enrollment and adverse-event denominators do not establish the denominator used for the primary endpoint.

The adverse-event group is labeled “MANTA Device (ITT Population),” but the record does not define that population or explain how it relates to the primary-endpoint analysis. The record also does not report an analysis population for the primary endpoint. As a result, the analysis set, handling of incomplete records, and any resulting risk of bias are not assessable from the registry record.

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: arrhythmia (7.4%), heart block/conduction disorder (7.0%), stroke/cerebrovascular accident (2.7%), anemia/decreased hematocrit (1.9%), pseudoaneurysm (1.9%).

The registry lists a group titled “MANTA Device (ITT Population)” with 258 at risk for serious adverse events and 73 affected. For other adverse events, it lists 258 at risk and 102 affected. The record also lists 1 death. These are the safety figures recorded for this group; the registry record does not report event attribution or establish that an event was caused by the device.

The listed serious adverse-event terms and percentages are Arrhythmia, 7.4%; Heart Block/Conduction Disorder, 7.0%; Stroke/Cerebrovascular accident, 2.7%; Anemia/decreased hematocrit, 1.9%; Pseudoaneurysm, 1.9%; and Heart failure, 1.2%. The record does not provide term-specific counts or say whether a participant could appear under multiple terms. These percentages should therefore be read as reported term-level figures, not added together or interpreted as exclusive shares of participants.

The record does not report whether the listed death was related to the device or procedure, or how serious events were judged for relatedness. Nor does it report a comparator group for assessing relative safety. The counts describe what the registry recorded; they do not establish causation or comparative risk.

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

The registry’s primary question is clinically specific: how often participants experienced a VARC-3 major or minor vascular complication within 30 days following TAVR with MANTA closure in the described standard-of-care setting. The outcome definition and event-review role are stated. However, the primary-endpoint percentage and its 95% confidence interval are not reported in the registry record. The central frequency and its precision therefore cannot be interpreted.

The safety fields do report counts for serious and other adverse events, along with a list of serious-event terms and percentages. These figures are descriptive of the recorded group. Without attribution information, they do not establish whether events were caused by the device or procedure. Without a reported comparator, they do not show whether outcomes were more or less frequent than under another closure approach.

The observational design also limits causal interpretation. Outcomes in a registry can reflect clinical selection and care practices as well as the device being evaluated. The study description emphasizes on-label use, appropriate patient selection, and proper vascular access, but the registry does not report enough detail to assess how these conditions varied or how they were incorporated into analyses. No adjustment or comparative analysis is reported.

General explanation: an observed outcome frequency is a description of what occurred in the population analyzed; a causal treatment effect asks what would have occurred under an alternative treatment for comparable participants. Estimating that contrast generally requires a defensible comparison and assumptions about confounding. This registry record does not report such a comparison, so causal claims are not supported by the available information.

The findings recorded should not be interpreted as proof that the device is safe or unsafe, or as proof that it improves or worsens outcomes. The record supports statements about the study’s purpose, endpoint definition, and posted safety counts. It does not provide the primary outcome result, a comparative estimate, or the analysis details needed to judge statistical precision and robustness.

14. Why This Trial Matters Statistically

This registry is statistically relevant because it focuses on a defined clinical outcome in a real-world procedural setting. The primary endpoint uses an established classification framework, combines major and minor vascular complications, and specifies a 30-day follow-up window. The record also states that a clinical events committee reviewed and classified reported events. These features clarify what the investigators intended to measure, even though the numerical primary result is not reported.

Its observational design makes the distinction between description and comparison especially important. A registry can document outcomes under stated clinical-use conditions, but a single-group result cannot by itself separate device-associated outcomes from patient selection, procedure characteristics, or other aspects of care. The record identifies no comparator and reports no randomized allocation. Readers therefore need to interpret the safety counts as descriptive rather than as a controlled estimate of relative performance.

The record also illustrates why outcome definitions and analysis reporting must be considered together. A defined endpoint is not enough to judge a result if the estimate, confidence interval, denominator, missing-data handling, and analysis population are unavailable. Here, the endpoint definition is stated, but its percentage and confidence interval are not reported. The registry lists 10 outcome measures and 0 analyses, leaving no reported analysis results with which to assess precision or consistency across outcomes.

Finally, the adverse-event entries show how safety listings require careful interpretation. Counts and term-level percentages can document reported events, but absent attribution and a comparison group they cannot establish causality or relative risk. Statistical clarity depends not only on the event list but also on how events were defined, counted, followed, and analyzed. Those details remain limited in this record.

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 interpretation is that the registry record does not report the primary-endpoint percentage or its stated 95% confidence interval. Without those values, readers cannot assess the frequency or precision of the outcome that defines the study’s main question. Secondary-outcome results are also not reported in the registry record.

The design is observational, and the record does not identify a comparator or report a like-for-like control comparison. It also does not state an allocation method. Consequently, the available figures cannot support a causal or comparative estimate. The clinical setting is described as on-label use in standard-of-care TAVR with appropriate patient selection and proper vascular access, but the registry does not report detailed participant characteristics or how these conditions were evaluated.

Important analysis details are absent. The record lists 0 analyses and does not report the primary-endpoint denominator, the analysis population, methods for missing data, the confidence-interval method, or any adjustments for participant or procedural differences. It does not report a multiplicity plan despite listing 10 outcome measures. These omissions prevent assessment of analysis choices and robustness; they do not establish that a particular method was or was not used outside the registry record.

The safety entries also have limits. The record does not report whether adverse events were considered related to the device or procedure, does not provide term-specific counts for the listed serious events, and does not clarify whether participants could contribute to multiple terms. The listed death has no reported attribution. Because no comparator is identified, the safety counts do not provide a relative-risk estimate.

Finally, the registry’s planning description is not a substitute for a reported design justification or analysis. It describes an illustration based on an observed effect and specified assumptions, but the record does not report the original sample-size rationale or numerical planning results. These limitations restrict what can be concluded from the posted record without determining the quality of analyses that may exist outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes — NCT05936996.
• Registry record last updated 2026-10-23; status last verified 2026-07.
• Results first posted 2026-10-23.
• 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

NCT05936996 is a completed observational registry titled “Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes.” It evaluates the MANTA Vascular Closure Device in TAVR procedures. The registry lists an enrollment of 258, a start date of 2023-11-15, and a primary completion date of 2025-06-20. Essential Medical, Inc. is identified as the sponsor.

The primary endpoint is the percentage of participants with one or more VARC-3 major or minor vascular complications within 30 days after TAVR. The record specifies a 95% confidence interval and committee review of reported events, but the primary estimate and interval are not reported in the registry record. The record lists 10 outcome measures and 0 analyses.

Safety fields list 73 affected among 258 at risk for serious adverse events, 102 affected among 258 at risk for other adverse events, and 1 death. The record does not report event attribution or a comparator. These safety figures are descriptive and do not establish causation or comparative risk.