Portico and Navitor India Clinical Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Portico and Navitor India Clinical Trial (NCT05171712), a na na study. The primary outcome is VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure.

2. Clinical Question

The trial’s stated objective was to collect information on procedural safety and device performance for Portico and Navitor devices and the FlexNav delivery system in patients with severe aortic stenosis in the Indian population. Its primary endpoint concerns the number of participants experiencing all-cause mortality within 30 days after the implant or index procedure. The registry record does not report a result for that endpoint, so the primary question cannot be answered from the posted results.

3. Trial Design

This is a completed, single-group trial record with an enrollment of 30. The allocation field is recorded as NA, masking is listed as NONE, and the model is SINGLE GROUP. The record lists transcatheter aortic valve replacement as the intervention and identifies Portico and Navitor devices, together with the FlexNav delivery system, in the trial objective. Although safety information is separated into Portico Valve and Navitor Valve groups, that division does not make the trial a randomized comparison. The registry explicitly cautions that the arms are not a like-for-like control comparison.

The record describes the intended population as patients with severe aortic stenosis in India. The arm description refers to people considered at high or extreme surgical risk who met inclusion criteria, did not meet exclusion criteria, and signed Ethics Committee-approved informed consent. The available description ends mid-sentence, so the complete operational definition of the analysis population is not reported in the registry record.

The record lists a start date of 2022-05-06, a primary completion date of 2024-12-21, and a status of COMPLETED. It identifies 19 outcome measures and no recorded analyses. The listed primary outcome is a VARC-2-defined all-cause mortality measure at 30 days after the implant or index procedure. A primary endpoint result is not reported in the registry record. Nor does the record describe randomization, a concurrent control group, or a masking procedure. These features limit the design’s ability to support direct causal comparisons between devices or against another treatment.

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:

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 VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure, measured over 30 days post index procedure.

The primary endpoint is the count of participants with all-cause mortality at 30 days after the implant or index procedure. The outcome title also expresses the measure as a percent of subjects, but its recorded parameter is a count of participants. No observed count or percentage is reported in the registry record.

All-cause mortality includes death from any cause within the defined follow-up window, rather than only deaths judged to be caused by the procedure or device. A fixed follow-up point gives the endpoint a clear time frame for describing early outcomes after the index procedure. The record says that outcomes are defined using VARC-2 definitions and refers to the published VARC-2 framework. It does not provide further endpoint adjudication details, explain how follow-up was completed, or state how deaths with uncertain timing or cause would be handled.

Mortality is a patient-level event, so the endpoint is naturally expressed as the number of participants with an event. The actual result is essential to interpret the endpoint: without it, neither the event frequency nor the precision of an estimate can be assessed. The registry record does not report a confidence interval, a denominator specific to the primary endpoint, or an analysis result. The recorded enrollment of 30 should not be treated as a substitute for the number with complete 30-day endpoint information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends first on identifying the design, outcome, and analysis actually recorded. The design is described as SINGLE GROUP, with allocation NA and masking NONE. The intervention is transcatheter aortic valve replacement. Portico Valve and Navitor Valve are named in the safety information, but their presence as separate groups does not establish randomized assignment or a controlled device comparison. The registry itself cautions that the arms are not a like-for-like control comparison. A comparison of group counts is therefore descriptive unless a suitable design and analysis establish otherwise; no such analysis is recorded.

What does the primary endpoint count?

The primary measure is the number of participants experiencing all-cause mortality at 30 days after the implant or index procedure. A count is the number of participants meeting the endpoint definition. Although the outcome title also refers to a percent of subjects, the recorded parameter is a count of participants. The record does not post the endpoint count, its denominator, or an estimate of the percentage. Those missing elements prevent a numerical interpretation of the primary outcome.

A fixed-time binary outcome classifies each participant as having or not having the event within the stated window. In general, a proportion summarizes the share of an analysis population with the event, while a confidence interval describes uncertainty around an estimated quantity. These are general statistical concepts; the registry record does not report a primary estimate or confidence interval to interpret. The recorded enrollment of 30 does not by itself establish the endpoint denominator because the number with observed 30-day status is not stated.

What can the adverse-event counts establish?

The safety information reports counts of participants at risk and participants affected for serious and other adverse events in each valve group. These are descriptive summaries. They indicate how many participants are recorded as affected in the corresponding group, but the record does not state the adverse-event follow-up period, event-level definitions, or whether a participant could contribute to more than one event term. Counts should not be treated as event rates over person-time, because no person-time information is reported. Nor should the group counts be treated as results from a randomized comparison.

In general, when outcomes are binary, comparing groups requires attention to how assignment occurred, the populations included, and the estimand being targeted. Randomization can support a causal interpretation by balancing measured and unmeasured factors on average, while a nonrandomized grouping may reflect differences between the people in each group. Here, allocation is listed as NA and the record warns against treating the arms as like-for-like controls. No adjusted analysis is recorded to address possible differences. This is why the counts are best read descriptively.

What does the analysis status mean?

The record lists 19 outcome measures and 0 analyses. In this context, the absence of recorded analyses means that inferential results such as model-based estimates, hypothesis tests, or confidence intervals are not posted. It does not show whether analyses were conducted outside the registry record. The record does not report a statistical analysis plan, the choice of statistical tests, covariate adjustment, or an approach to repeated or correlated outcomes.

Multiplicity is a general concern when many outcomes or comparisons are evaluated: the chance of at least one apparently notable result can increase if many tests are conducted without an appropriate plan. The count of outcome measures alone does not tell whether or how multiplicity was handled. Since no analyses are recorded, no multiplicity adjustment or testing hierarchy can be assessed.

How should planning calculations be understood?

General sample-size calculations estimate how much information may be needed to detect a specified effect under stated assumptions. They are planning exercises, not evidence about what happened in a trial. The record’s sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. The illustration is not the trial’s own design justification, and the registry does not report a sample-size justification. Any such planning output should be interpreted as hypothetical rather than as observed power or a result of the trial. The record does not provide a design justification or interim-analysis plan.

In general, over-dispersion occurs when outcome variability is greater than a model assumes, which can make standard errors too small if the model is not adapted. That concept is not directly assessable from the posted information: the primary endpoint is described as a participant count, and no fitted model, variance estimate, or analysis is reported. More broadly, statistical methods should match the endpoint and design, but the methods used for the trial are not reported in the registry 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("Portico Valve", "Navitor Valve")
n      <- c(20, 10)
events <- c(3, 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  Portico Valve  20  3  15.0  3.2  37.9  5.2  36.0  5.4  36.3
ARM  Navitor Valve  10  0  0.0  0.0  30.8  0.0  27.8  0.2  28.5

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 19 outcome measures and 0 analyses. It does not report a statistical analysis plan, a hierarchy of primary and secondary hypotheses, or an adjustment for testing multiple outcomes. In general, evaluating many outcomes can increase the chance of finding an apparently notable result by chance if tests are conducted without a suitable plan. The number of listed outcomes does not reveal whether formal testing was performed or whether multiplicity was addressed. Since no analyses are recorded, the handling of multiplicity is not reported in the registry record.

Missing-data handling is also not reported. The record does not say how participants with no 30-day status were handled, whether follow-up was complete, or whether any imputation or sensitivity analysis was used. Although the overall enrollment is 30, the number contributing to the primary endpoint is not stated. A reader therefore cannot assume that all enrolled participants had complete endpoint information.

The arm description gives some eligibility and consent information and refers to an analysis population of people at high or extreme surgical risk. Its text is incomplete, so the full definition is not reported in the registry record. The record does not state whether the primary outcome used an intention-to-treat, per-protocol, safety, or other analysis population. It also does not specify how participants with protocol deviations, missing measurements, or incomplete follow-up were treated. These details matter because outcome counts and comparisons depend on who is included and how incomplete information is handled.

Finally, there are no recorded analyses to clarify denominators, exclusions, or endpoint adjudication. The primary endpoint result and its precision are not posted. Thus, neither multiplicity control nor missing-data assumptions can be evaluated 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: valve mirgation (10.0%), anemia (10.0%), bradycardia (5.0%), cardiac performation (5.0%), dyspnea (5.0%).

For Portico Valve, the safety information records 7 of 20 participants at risk as affected by serious adverse events and 10 of 20 as affected by other adverse events. For Navitor Valve, the corresponding counts are 1 of 10 for serious adverse events and 7 of 10 for other adverse events. The death counts are 3 and 0, respectively. These figures are descriptive counts within the recorded groups, not adjusted comparisons or randomized treatment effects.

The registry also lists serious-event terms with percentages: Valve mirgation and Anemia at 10.0% each, and Bradycardia, Cardiac performation, Dyspnea, and Anxiety at 5.0% each. The record does not make clear whether these terms overlap within participants, the event observation period, or whether the percentages use the full group or another denominator. The listed terms should therefore be read as registry entries rather than as a complete account of event burden.

The record does not state the time frame for the serious and other adverse-event counts or clarify how the death counts relate to the 30-day primary endpoint. The figures alone do not establish comparative safety, and they do not show that an event was caused by a device or procedure.

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

The record establishes that a completed trial was registered with an enrollment of 30 and that its objective concerned procedural safety and device performance for Portico and Navitor devices and the FlexNav delivery system in Indian patients with severe aortic stenosis. It identifies a 30-day all-cause mortality endpoint and gives descriptive safety counts by valve group. It does not report the primary endpoint result, its denominator, or a measure of statistical uncertainty.

That distinction matters. An endpoint definition tells the reader what outcome was intended to be measured; it does not reveal what was observed. Without a posted count and denominator, the primary outcome cannot be quantified. Without a confidence interval or other uncertainty estimate, its precision cannot be judged. The record’s enrollment figure does not fill either gap, because it does not establish complete endpoint follow-up.

The adverse-event counts can be described as the numbers recorded in each group, but not as proof that one device caused more or fewer events. The trial is listed as single-group, allocation is NA, and the registry cautions that the arms are not a like-for-like control comparison. Differences in descriptive counts can reflect differences in group composition, follow-up, or other factors that are not characterized in the posted information. No inferential analysis is recorded.

Likewise, a planning illustration is not an outcome result. General sample-size calculations address hypothetical design assumptions; they do not establish that an observed effect is real, clinically important, or precisely estimated. The posted record does not supply a sample-size justification or analysis plan. The results should therefore be understood as limited registry information rather than a complete statistical evaluation of the trial.

In short, the registry record describes the question and gives some safety observations, but it does not answer the primary mortality question. It also does not provide a valid basis for concluding that Portico or Navitor is superior, equivalent, or safer than the other or than an unlisted alternative.

14. Why This Trial Matters Statistically

This trial is statistically notable because its registry record presents two valve groups while also identifying the model as SINGLE GROUP and allocation as NA. That combination makes it important to distinguish descriptive group summaries from comparative evidence. Separate counts can be useful for documenting observed events, but the group labels alone do not create a controlled comparison. The registry explicitly cautions that the arms are not a like-for-like control comparison.

The record also highlights how endpoint definition and endpoint reporting are different. It names a specific primary measure, all-cause mortality at 30 days after the implant or index procedure, and points to VARC-2 definitions. Yet the result itself is not reported. Without the event count and endpoint denominator, readers cannot estimate the observed frequency; without an uncertainty measure, they cannot assess precision. Clear definitions are valuable, but they cannot substitute for results.

The safety summaries show why denominators and follow-up details matter. Counts of affected participants are interpretable only in relation to the group at risk and the period during which events were collected. The record provides group counts but does not report the observation window for adverse events or explain how the death counts align with the primary endpoint. That leaves important questions about comparability and interpretation unanswered.

Finally, the record lists 19 outcomes but no analyses. This makes it impossible to assess whether there was a prespecified testing strategy, how missing data were handled, or whether uncertainty was quantified. These are core components of statistical interpretation, especially when a record has multiple outcome measures. The trial is a useful illustration of why design labels, outcome definitions, denominators, and analysis results all need to be considered together.

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 primary endpoint result is not reported in the registry record. Its denominator, confidence interval, and the number of participants with complete 30-day follow-up are also not stated. As a result, the principal outcome cannot be evaluated quantitatively from the posted information.

The design is recorded as SINGLE GROUP, allocation is NA, and the registry cautions that the Portico Valve and Navitor Valve groups are not a like-for-like control comparison. The safety counts therefore cannot establish a causal difference between devices. No adjusted analyses are recorded, and no information is given about participant characteristics by group that might help assess comparability.

The adverse-event observation period and event ascertainment methods are not reported. The record does not clarify whether serious events and deaths were counted over the same period as the primary endpoint, whether event terms could overlap within participants, or how event attribution was determined. The listed terms and counts do not provide a complete account of follow-up or event severity beyond the registry categories.

The analysis population description is incomplete, ending mid-sentence in the registry record. The full eligibility and analysis-population rules are therefore not available. The record does not describe missing-data procedures, protocol deviations, endpoint adjudication processes, or a statistical analysis plan. It lists 19 outcomes but no analyses, leaving multiplicity and model choices unassessable.

The recorded enrollment is 30, but no sample-size justification is reported. Planning assumptions are not a substitute for a design justification or for observed results. These limitations restrict the conclusions that can be drawn from the registry record and make it inappropriate to interpret the posted safety counts as comparative evidence.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Portico and Navitor India Clinical Trial — NCT05171712.
• Registry record last updated 2026-04-15; status last verified 2026-04.
• Results first posted 2026-04-15.
• 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 Portico and Navitor India Clinical Trial is recorded as COMPLETED, with a start date of 2022-05-06, primary completion date of 2024-12-21, and enrollment of 30. Its stated objective was to collect data on procedural safety and device performance for Portico and Navitor devices and the FlexNav delivery system in Indian patients with severe aortic stenosis.

The design is listed as SINGLE GROUP, with allocation NA and masking NONE. The primary endpoint is VARC-2-defined all-cause mortality at 30 days after the implant or index procedure. The registry lists 19 outcome measures and 0 analyses. It reports safety counts for Portico Valve and Navitor Valve groups, while cautioning that they are not a like-for-like control comparison. The primary endpoint result and its precision are not reported in the registry record.