JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study (NCT02732691), a na na study. The primary outcome is All-Cause Mortality.

2. Clinical Question

The registry’s brief description says the study was intended to collect information about treatment for severe aortic stenosis. It also describes aortic valve replacement surgery as the preferred treatment for severe disease. The trial record focuses on a transfemoral transcatheter valve system, but it does not set out a comparator arm or a treatment-effect contrast.

The record lists 68 participants as enrolled. It identifies all-cause mortality at 30 days as the primary outcome and lists additional outcomes including myocardial infarction, stroke or transient ischemic attack, major bleeding, vascular complications, conduction disturbances and arrhythmias, acute kidney injury, coronary obstruction requiring intervention, and endocarditis. Those additional outcomes broaden the safety and performance questions, but their results are not detailed in the registry record beyond the adverse-event summary.

3. Trial Design

This is a single-group device study of the JenaValve Pericardial TAVR System in patients with symptomatic severe aortic stenosis. The study is listed as having no masking, and allocation is recorded as not applicable. No randomized allocation or concurrent control group is described. The arm is titled Transcatheter Aortic Valve Replacement (TAVR), and its description specifies use of the JenaValve pericardial valve and delivery system.

The registry lists an enrollment of 68. The recorded start date is 2016-10-21, and the primary completion date is 2019-05-28. The study status is listed as UNKNOWN. The record identifies the sponsor as JenaValve Technology, Inc. The phase is listed as NA.

The primary endpoint is all-cause mortality, measured as participants, with a 30 Day timeframe and an enrolled population. The record also lists secondary outcomes covering cardiovascular events, bleeding, vascular and conduction complications, kidney injury, coronary obstruction and endocarditis. It lists 11 outcome measures, while the analyses count is 0. Thus, the record names outcome measures but does not provide a corresponding set of analysis descriptions.

In a single-group design, observed outcomes describe what occurred among the people in that group. Without a concurrent comparison group, differences from another treatment or from usual care cannot be estimated directly from the trial structure. This is a design limitation for comparative inference, not evidence that any particular outcome is better or worse. The registry does not report a protocol rationale for choosing the design, a sample-size justification, or a detailed analysis plan.

The posted planning illustrations are based on the observed effect and describe hypothetical two-arm calculations under stated assumptions. They should not be read as the original design of this single-group study or as evidence that an observed comparison was conducted. The record does not report the trial’s own power calculation or design assumptions.

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: Enrolled

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: Enrolled

6. Primary Endpoint

The registry lists the primary outcome as All-Cause Mortality, measured over 30 Day.

The primary endpoint is all-cause mortality at 30 days, expressed as the number of participants. All-cause mortality counts deaths regardless of their cause. A mortality endpoint is clinically important because it captures a severe outcome without relying on investigators to assign a specific cause. It is also readily interpretable when the outcome definition, timeframe and population are clearly specified.

For this study, the registry names a 30 Day timeframe and identifies the enrolled population. These details define the outcome the study intended to assess. However, the registry record does not report a primary endpoint result, such as the number of deaths in the specified timeframe or an accompanying estimate of uncertainty. The adverse-event summary separately lists 2 deaths, but it does not specify that count’s timeframe or link it explicitly to the primary endpoint. Those entries therefore should not be treated as interchangeable.

In general, a proportion or count from a single group describes observed outcomes in that group. It does not by itself show what would have happened to the same participants under another treatment. A comparison requires an appropriate comparator and an analysis designed to account for the study design. Here, the single-group structure means the primary outcome is a descriptive safety or performance measure rather than a randomized comparative treatment effect.

The 30-day endpoint also addresses a defined period rather than mortality over all subsequent follow-up. The registry record does not report additional detail about how follow-up was handled, how the endpoint was ascertained, or whether the reported endpoint population included all enrolled participants in the analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation begins with the design. This is a single-group study, with no masking and allocation recorded as not applicable. In general, a single-group study estimates outcomes within the group receiving the intervention. It does not produce the randomized contrast that would come from assigning participants to intervention and control groups. Differences from an external benchmark may be explored in other settings, but the registry record does not report such a comparison or its assumptions.

What does a participant count represent?

The primary outcome is specified as all-cause mortality measured in participants. A participant count describes how many people meet the endpoint definition during the specified period. It is distinct from a count of event episodes: one participant may have more than one event of a different kind, while a participant-based endpoint counts whether the person met the definition. The registry’s outcome description names a participant count, but it does not provide the primary result for the stated 30-day period.

In general, a binary outcome has two states for each participant: the event occurred or it did not. A proportion is often used to summarize such outcomes, and an interval estimate can show uncertainty around that proportion. No primary-outcome proportion or interval is reported in the registry record. The posted adverse-event summary gives participant counts and percentages for selected serious terms, but it does not supply an inferential analysis or uncertainty interval for those entries.

Why does the absence of a comparator matter?

A comparative treatment effect requires a comparison between outcomes under different treatment conditions. Randomization can help make the groups comparable on average, while a prespecified analysis accounts for the design and outcome definition. This record describes one treatment group, not a randomized comparison. As a result, an observed count in the TAVR group cannot be attributed to the intervention by comparing it with an unobserved alternative outcome. It can be described as an outcome observed in this group, with the limitations of the registry’s reporting.

General statistical interpretation also distinguishes association from causation. Events occurring after a procedure are temporally observed after treatment, but that fact alone does not determine their cause. The adverse-event summary identifies event categories and counts; the registry does not report a causal assessment for those events.

How should precision be understood?

General explanation: a confidence interval is a range calculated from data and a statistical model to communicate uncertainty around an estimate. It is not a guarantee that the underlying value lies in the interval. The interval’s width depends on the amount and variability of information and on the analysis method. The record does not report a confidence interval for the primary endpoint, and the available endpoint entry does not support a judgment about its precision.

For a binary outcome, methods for estimating uncertainty may use different assumptions, particularly when counts are sparse. The registry record does not name a method for the primary outcome or provide sufficient results to compare alternative methods. No estimate should be recreated from the adverse-event counts as if it were the missing primary endpoint result.

What do the planning assumptions mean?

The planning illustrations use a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. They are described as planning illustrations computed from the observed effect, with the target effect set as a stated fraction of that observed effect. In general, such calculations ask how many participants a hypothetical study might require to detect a specified effect under assumed conditions. They are not observed outcomes, and they do not show that the original trial had that design.

The illustrations distinguish total event counts for time-to-event calculations from participants per arm for other calculations. The registry record does not report a time-to-event primary endpoint; its primary outcome is a participant count at 30 days. The planning assumptions therefore should not be used to imply that the trial conducted a time-to-event analysis. The original study’s sample-size justification and statistical plan are not reported in the registry record.

General explanation: over-dispersion occurs when outcome variability is greater than a model’s assumptions allow. If it is present, standard errors can be too small and intervals too narrow unless the analysis accounts for it. The listed primary outcome is binary, and the record does not report an over-dispersion assessment or a model that would make this issue an established feature of the study. It is a general consideration, not a finding about this trial.

The analysis count is 0 in the registry record. No adjusted analysis, hypothesis test, or prespecified statistical model is described. Consequently, interpretation should stay with the reported design and descriptive outcome information rather than imply an unreported inferential analysis.

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("Transcatheter Aortic Valve Replacement (TAVR)")
n      <- c(68)
events <- c(2)
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  Transcatheter Aortic Valve Replacement (TAVR)  68  2  2.9  0.4  10.2  0.8  10.1  0.9  10.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures, including mortality and a range of cardiovascular, bleeding, vascular, conduction, kidney, coronary and infectious outcomes. When a study examines multiple outcomes, the chance of at least one apparently unusual result can increase if many separate statistical tests are performed. General approaches include prespecifying a primary outcome, adjusting for multiple comparisons, or interpreting secondary outcomes as exploratory. The registry record does not report a multiplicity strategy, and it lists 0 analyses. It is therefore not possible to determine whether any adjustment or hierarchy was planned or used.

The record identifies all-cause mortality at 30 days as the primary endpoint and the enrolled population as the endpoint population. However, it does not report a result for that endpoint, an analysis population definition beyond enrolled participants, or whether participants with missing endpoint information were included. Missing outcome data can affect both the estimated event frequency and the precision of an estimate; the direction and size of any effect depend on why data are missing and how they are handled. Those details are not reported in the registry record.

The record also does not describe imputation, censoring, loss to follow-up, exclusions, or sensitivity analyses. These are reporting gaps, not evidence that any particular data problem occurred. The posted adverse-event entries include participants at risk and participants with events, but the record does not explain the handling of missing safety information. Without those methods and a primary result, the reported counts cannot establish how complete follow-up was or how missingness might affect interpretation.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: other infection (11.8%), bleeding complication (7.4%), conduction disturbance (7.4%), stroke/tia (5.9%), bleeding (major) (4.4%).

The adverse-event summary lists 68 participants at risk for serious events and 39 participants affected; it lists 68 at risk for other adverse events and 23 affected. These are participant counts in the registry’s categories, not necessarily counts of separate event episodes. The record also lists 2 deaths, but does not specify the timeframe for that count in the adverse-event entry. It should not be assumed to equal the 30-day primary endpoint result.

Among the serious-event terms, the registry lists Other Infection at 11.8%, Bleeding Complication at 7.4%, Conduction Disturbance at 7.4%, Stroke/TIA at 5.9%, Bleeding (Major) at 4.4%, and GI Complication at 4.4%. These percentages are registry entries. The record does not explain in this summary whether participants could be represented in more than one term, how recurrent events were handled, or whether each term’s percentage uses the same event-counting rules.

These data describe safety observations in the treated group. They do not, by themselves, show that the treatment caused an event, nor do they establish comparative risk because no control group is described. The registry does not report a formal safety analysis or uncertainty intervals for these figures.

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

The posted record establishes that the study evaluated the JenaValve pericardial TAVR system in a single group of patients with symptomatic severe aortic stenosis. It identifies all-cause mortality at 30 days as the primary endpoint and lists additional outcome areas. It also provides adverse-event counts and selected serious-event percentages. These details help describe what was studied and what safety information the registry records.

The record does not report a specific result for the primary endpoint. Although the adverse-event summary lists 2 deaths, it does not specify that those deaths occurred within the primary endpoint’s 30-day timeframe. The two entries should therefore remain distinct in interpretation. The registry also does not provide an uncertainty interval or an analysis of the primary endpoint.

The study’s single-group design does not support a randomized comparison with another treatment or with no treatment. The observed event counts cannot establish what would have happened to the same patients under an alternative. Likewise, the safety counts do not establish that the device or procedure caused the reported events. Those are limits on what this record can show, not conclusions about the underlying clinical value of the intervention.

In general, a study result is most informative when the endpoint definition, follow-up period, analysis population, missing-data handling and statistical uncertainty are reported alongside the observed estimate. Several of those details are not reported in the registry record. The available information consequently supports a cautious, descriptive reading of the design and adverse-event summary, rather than a conclusion about comparative effectiveness or the precision of the primary endpoint.

14. Why This Trial Matters Statistically

This trial is statistically notable because it asks an important safety and performance question using a single-group design. That structure can document outcomes among treated participants, but it cannot directly estimate a treatment contrast against a concurrent control. Readers should therefore distinguish descriptive event reporting from evidence of a comparative effect.

The primary endpoint is clearly named as all-cause mortality at 30 days in enrolled participants. Yet the registry record does not report the endpoint result or its uncertainty. The adverse-event summary includes a death count, but its timeframe is not given in that entry. This makes careful separation of outcome definitions essential: a count in a safety summary cannot automatically be substituted for a result on the specifically defined primary endpoint.

The record also makes visible the difference between listing outcomes and reporting analyses. It names 11 outcome measures, while the analyses count is 0. A broad outcome list can signal the range of issues tracked, but without analysis details and results, it cannot show how each outcome was evaluated or how multiplicity was addressed.

Finally, planning illustrations based on an observed effect are not the same as the original study’s design rationale or an observed measure of power. Their assumptions describe hypothetical calculations, while the trial itself is recorded as single-group. Keeping these concepts separate helps prevent planning outputs from being mistaken for evidence generated by the trial. In this record, the most defensible statistical reading is limited to the design, stated endpoint, enrollment, and posted adverse-event summaries.

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.

Several limitations arise from the specific information recorded for this study. First, no comparator group is described, so the registry record does not support a direct estimate of how outcomes differ from another treatment or control. Allocation is listed as not applicable, and the study is identified as single-group. The absence of a concurrent comparison limits causal interpretation of outcomes observed after treatment.

Second, the primary endpoint is named but its result is not reported in the registry record. The adverse-event summary includes 2 deaths without specifying the timeframe, so that count cannot be assumed to represent all-cause mortality at 30 days. The record also does not provide a confidence interval or another measure of precision for the primary endpoint.

Third, the registry does not report the original sample-size justification, a statistical analysis plan, or analysis methods. It lists 11 outcome measures and 0 analyses. There is no reported multiplicity strategy, missing-data procedure, follow-up completeness assessment, or detailed analysis-population definition. These omissions prevent assessment of how those issues were handled; they do not establish that the study had a particular flaw in conduct.

Finally, the adverse-event summary does not fully describe event ascertainment, repeated events, overlap between categories, or the timeframe for the death count. The listed counts and percentages are therefore best read as registry summaries with limited methodological context. The status is recorded as UNKNOWN, and the record does not provide additional context that resolves that status.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study — NCT02732691.
• Registry record last updated 2022-11-22; status last verified 2022-10.
• Results first posted 2022-11-22.
• 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

The registry record describes the JENAVALVE ALIGN-AS trial of the JenaValve pericardial TAVR system for patients with symptomatic severe aortic stenosis. It is a single-group study with no masking; allocation is listed as not applicable. Enrollment is 68, the recorded start date is 2016-10-21, and the primary completion date is 2019-05-28. The status is listed as UNKNOWN.

The primary endpoint is all-cause mortality at 30 days among enrolled participants. The record lists 11 outcome measures and 0 analyses. Its adverse-event summary lists 39 participants with serious events, 23 with other adverse events, and 2 deaths, with the death count’s timeframe not specified in that summary. A specific 30-day primary endpoint result and its statistical uncertainty are not reported in the registry record.