EasyCrossTM Device-Self-centering Catheter: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for EasyCrossTM Device-Self-centering Catheter (NCT06412354), a na na study. The primary outcome is Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device.

2. Clinical Question

The clinical question is whether use of the catheter in this first-in-human setting was accompanied by reported AEs or SAEs during the stated assessment period. The registry records zero participants with a serious event and two participants with other adverse events in the study group. These are descriptive findings from the enrolled group, not estimates from a controlled comparison. They do not by themselves determine whether an event was caused by the device, and they do not establish how event counts would compare with another approach. The registry also lists time spent crossing the valve as a secondary outcome, but its result is not reported in the registry record.

3. Trial Design

This was a prospective, open-label, non-randomized, single-group, first-in-human feasibility trial of the VIVHEART EasyCross catheter. The registry describes the study as single-center. The trial record lists 20 participants and a completed status. The listed start date is 2024-02-12 and the primary completion date is 2024-07-15.

All participants were assigned to the VIV-FIH group; there was no randomized allocation or separate control arm. This design can describe what was observed among people treated with the device in the study, but it cannot distinguish device-related effects from events associated with the underlying procedure, other care, or participant characteristics. Because the trial was open-label, knowledge of device use was not masked. Whether outcome assessment involved additional safeguards against observer expectations is not reported in the registry record.

The intervention was a device used during TAVR to facilitate guidewire passage through the aortic valve. The registry summary describes a catheter with a distal expandable basket intended to move the catheter away from vessel walls. The proposed aim was to reduce attempts and time needed to cross the valve and improve procedural safety; these are stated aims, not findings established by the adverse-event counts.

The primary endpoint concerned participants with AEs or SAEs linked or not linked with the device. Assessment timepoints were the procedure day, one week, and four weeks. The registry also lists a secondary outcome for time spent crossing the valve, but does not report its result. Detailed eligibility criteria, enrollment procedures, follow-up completion, and the full protocol are not reported in the registry record. The phase is listed as NA. This is a feasibility study, not a randomized trial designed to estimate a comparative treatment effect.

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

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 Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device, measured over Day of procedure; 1 week; 4 week.

The primary endpoint counts participants who experienced an AE or SAE, including events described as linked or not linked with the EasyCross device. The registry frames the endpoint as a safety assessment and specifies the procedure day, one-week, and four-week timepoints. It also describes adverse events of special interest: intra-operative death, a complication due to device malfunction during the procedure, an embolization event, and an allergic reaction.

Counting participants with events is a straightforward way to describe how many people in the study group had a recorded safety event. The participant count is distinct from a count of all event episodes: a person with multiple events may still contribute as one participant to a participant-based endpoint. The registry’s primary outcome is explicitly expressed as a number of participants. It does not report a separate total count of event episodes or a breakdown of the two other adverse events by type.

Safety endpoints are relevant in a first-in-human feasibility study because they document events occurring during initial use of a device and its associated procedure. They can identify observations that merit further examination. However, a single-group count does not show whether the device increased or reduced event occurrence relative to an alternative. Nor does the endpoint description alone establish the cause of any event. The registry reports zero participants with serious events and two with other adverse events; attribution details beyond the endpoint’s linked-or-not-linked framing are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The reported primary outcome is a participant count. Understanding the method begins with keeping the unit of analysis clear: the result concerns people with an event, not necessarily the total number of event episodes. The registry lists 20 participants at risk for serious events and 20 at risk for other events. In the serious-event group, zero participants were affected; in the other-event group, two were affected. No separate inferential analysis is reported in the registry record.

What does a participant count tell the reader?

A count describes the number of people meeting the endpoint definition in the study group. Counts are directly interpretable but depend on the number of people observed and on how events were defined and collected. Here, the endpoint covers AEs and SAEs linked or not linked with the device, and the assessment timeframe includes the procedure day, one week, and four weeks. The registry does not provide a detailed account of event ascertainment, adjudication, or how multiple events in one person were handled beyond defining the outcome as a count of participants.

Counts should not be confused with comparative effects. A randomized comparison can estimate differences between assigned groups under its assumptions; this study has one group and no concurrent comparator. Consequently, there is no randomized contrast from which to estimate how the event count would differ under another approach. No adjusted or unadjusted effect estimate, hypothesis test, or p-value is reported in the registry record.

How should uncertainty be considered?

General statistical explanation: a confidence interval gives a range of values compatible with the data and the interval method, under its assumptions. It communicates precision rather than proving that a particular value is true. With a participant count and no reported interval, readers can see the observed count but cannot assess precision from an interval estimate in the registry record. In particular, a zero observed serious-event count should not be read as proof that the underlying possibility of such events is zero.

General statistical explanation: event counts can be analyzed with methods suited to binary outcomes, such as methods that estimate a proportion or compare proportions between groups. The appropriate choice depends on the design, outcome definition, and amount of information. In a one-group study, a descriptive proportion may characterize the observed group, but comparison with another group is not available unless external data and additional assumptions are introduced. No such comparative analysis is reported in the registry record, and no new estimate is calculated.

What can a planning calculation establish?

The trial record describes sample-size calculations as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the target effect is a stated fraction of the observed effect. Those assumptions describe a hypothetical planning exercise rather than the trial’s single-group design. The record does not report a trial-specific sample-size justification. Any sample-size result under those assumptions is a planning illustration, not observed power and not evidence that the study was designed to detect a particular effect.

General statistical explanation: power calculations concern the chance that a specified analysis would detect a specified effect if the assumptions and effect were true. They do not tell whether the observed result is reliable, and they cannot substitute for an uncertainty interval around the observed data. Planning numbers also depend on assumptions about the effect, variability, allocation, and analysis method. For this study, the underlying sample-size justification and protocol are not reported in the registry record.

Why does the study design constrain inference?

A single-group feasibility study is suited to documenting initial experience, including recorded safety events. It is not designed as a like-for-like controlled comparison in the registry information. Without randomization and a comparator, differences due to patient characteristics, procedure circumstances, or concurrent care cannot be ruled out as explanations for observed outcomes. Open-label conduct also means masking was absent. Whether this affected event recording or assessment cannot be determined from the registry information.

The registry lists zero statistical analyses. It does not report an analysis plan, interim analyses, handling of missing outcome data, or a defined analysis population. Those omissions prevent assessment of planned inferential procedures, multiplicity adjustments, or how incomplete follow-up might affect the endpoint. The appropriate reading is therefore a descriptive one: the posted group counts are the observed safety findings reported for this first-in-human study, with their limitations, rather than a formal estimate of comparative effect.

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("VIV-FIH")
n      <- c(20)
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  VIV-FIH  20  0  0.0  0.0  16.8  0.0  16.1  0.1  16.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the primary safety outcome and a secondary outcome for time spent crossing the valve. It reports zero analyses. A multiplicity strategy, including whether and how any adjustment across outcomes or analyses was planned, is not reported in the registry record. Without that information, the record does not establish a confirmatory testing hierarchy or a family-wise error approach.

Missing-data procedures and analysis populations are also not reported in the registry record. The listed risk groups include 20 participants for serious events and 20 for other events, but the record does not describe whether all enrolled participants completed every follow-up assessment or how incomplete assessments were handled. The primary endpoint spans the procedure day, one week, and four weeks, so follow-up completeness could affect interpretation of event ascertainment. No assumptions about missing outcomes should be inferred from the counts alone.

The registry does not report interim analyses, a statistical analysis plan, or details of an intention-to-treat or other analysis population. The study’s single-group, non-randomized design also means that a comparative treatment analysis is not specified by the available record. These omissions limit evaluation of whether the reported counts were analyzed according to a prospectively defined plan. The reported values can be read as descriptive participant counts, but the registry does not provide enough information to assess planned handling of missingness, multiplicity, or deviations from an analysis plan.

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: ae (0.0%).

The serious adverse-event listing reports zero participants affected among 20 at risk, and the deaths count is zero. The registry’s top serious-event term is AE at 0.0%. These figures indicate that no serious events or deaths were recorded in the posted group result. The other adverse-event count is two participants among 20 at risk; it is a participant count rather than a count of all event episodes.

These categories should remain distinct. The reported zero for serious events does not mean there were no adverse events of any kind, because the record separately reports two participants with other adverse events. Conversely, the other-event count should not be treated as two serious events. The registry does not report the specific types, timing, severity, or participant-level details of those other events.

The endpoint includes events described as linked or not linked with the device. Therefore, the counts alone do not establish causation. A zero serious-event count is an observation from this group and follow-up period, not proof that serious events cannot occur. The registry does not report a confidence interval or a comparative group, so precision and relative safety cannot be assessed from these counts alone.

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

The results establish a limited but useful descriptive fact: among the 20 participants listed at risk in the VIV-FIH group, zero had a reported serious adverse event, two had a reported other adverse event, and zero deaths were reported. These findings describe the study group during the registry’s stated safety assessment period of the procedure day, one week, and four weeks. The primary endpoint was defined to include events linked or not linked with the device.

They do not establish that the catheter caused, prevented, or reduced adverse events. There was no concurrent control group, and the study was non-randomized and open-label. The event counts cannot be interpreted as a comparison with another device or with usual care. Nor do the counts establish that any particular event was attributable to the catheter; event-level attribution details are not reported in the registry record.

The results also do not answer the device’s stated procedural aims. The study summary describes the device as intended to facilitate guidewire passage and potentially reduce attempts and time needed to cross the valve. The registry lists time spent crossing the valve as a secondary outcome, but that result is not reported in the registry record. No conclusion about crossing time or number of attempts follows from the available safety counts.

General statistical interpretation: observed counts are estimates of experience in the study group, and their precision depends on the amount and completeness of the observed data. No confidence interval is reported in the registry record, and the zero serious-event count does not demonstrate zero underlying risk. The study is a first-in-human feasibility trial, so its value lies in documenting initial observations rather than establishing comparative effectiveness or safety. Broader conclusions would require information not reported in the registry record, including comparative data and more detailed outcome results.

14. Why This Trial Matters Statistically

First-in-human feasibility studies have a distinct statistical role. Before a device is evaluated in a controlled comparison, an initial study can document how it is used and what safety events are recorded in the early study group. The VIV-FIH record reports a single-group experience with 20 participants at risk for each listed adverse-event category. Its serious-event count is zero, while two participants had other adverse events. Those observations are relevant as an initial account, even though they do not establish a comparative effect.

The design also illustrates why the structure of a study matters as much as the observed count. Without randomization or a control group, the data cannot isolate the contribution of the catheter from the procedure or other factors. A small first-in-human feasibility study is not a substitute for comparative evidence, and the registry does not report statistical analyses that would support a formal comparison.

Statistically, a zero observed count can be informative without being definitive. It records that no serious event was reported in the group, while uncertainty remains about events that might occur in broader use. A confidence interval or a carefully designed comparator study could address different aspects of that uncertainty, but neither is reported in the registry record.

The record also makes the difference between an intended benefit and a measured result important. The device is intended to facilitate valve crossing, and time spent crossing the valve is listed as a secondary outcome. Because that outcome’s result is not reported in the registry record, the safety counts cannot be used to evaluate the procedural aim. The trial matters statistically because it provides an early descriptive safety observation while making clear the limits of inference from a single-group feasibility design.

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 important limitation is the absence of a concurrent comparator. The study is single-group and non-randomized, so its safety counts cannot estimate a difference relative to another device or procedure. Open-label conduct is also reported; the potential effect of unmasked assessment on event recording is not described in the registry record.

The posted outcomes are limited in detail. The primary endpoint counts participants with AEs or SAEs, but the registry does not report event-level descriptions for the two participants with other adverse events. It does not report the timing, severity, or attribution of those events. The record lists zero serious events and zero deaths, but no confidence interval or formal statistical analysis accompanies these counts.

The trial is described as a first-in-human feasibility study with 20 participants at risk. The registry does not report the sample-size justification, detailed eligibility criteria, participant characteristics, or a statistical analysis plan. It also does not report the analysis populations, how missing outcome data were handled, whether follow-up was complete, or whether any interim analyses occurred. These omissions constrain assessment of precision and potential bias.

The secondary outcome for time spent crossing the valve is listed without a reported result. Therefore, the registry information does not allow assessment of the device’s intended procedural aims. The record also does not report detailed protocol information beyond the described design and endpoint. The findings should be interpreted as initial descriptive safety counts rather than proof of comparative safety, event causation, or procedural benefit.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: EasyCrossTM Device-Self-centering Catheter — NCT06412354.
• Registry record last updated 2026-04-22; status last verified 2024-05.
• Results first posted 2026-04-22.
• 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 NCT06412354, the VIVHEART EasyCross catheter first-in-human feasibility trial. It lists a prospective, open-label, non-randomized, single-group, single-center design and a completed status. Enrollment is listed as 20 participants. The intervention was the EasyCross device used during TAVR.

The primary outcome counted participants with AEs or SAEs, linked or not linked with the device, at the procedure, one week, and four weeks. The VIV-FIH group had zero participants with a serious event among 20 at risk, two with other adverse events among 20 at risk, and zero deaths. The secondary outcome of time spent crossing the valve is listed, but its result is not reported in the registry record. The registry lists zero analyses; further statistical methods and missing-data procedures are not reported in the registry record.