EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty (NCT01532921), a registered phase not stated study. The primary outcome is Mean Gradient Across the Tricuspid Valve.

2. Clinical Question

The primary measure is a continuous echocardiographic quantity reported as a mean in mmHg. The question is descriptive: it concerns the measured gradient at the stated time points in participants receiving the procedure and device. It is not framed as a comparison against a concurrent control group.

The registry also names changes from baseline through 6 months in right ventricle diastolic area, tricuspid annular diameter measured at diastole, right ventricle fractional area, and New York Heart Association classification. These measures address other aspects of cardiac structure, function, and clinical classification. Numerical findings for these outcomes are not reported in the registry record.

3. Trial Design

EASE TRICUSPID is a completed post-market study of the Contour 3D® Tricuspid Annuloplasty Ring. The registry record describes its purpose as evaluating the ring’s hemodynamic performance following tricuspid valve repair in a post-market environment. It identifies Medtronic Cardiac Rhythm and Heart Failure as the sponsor, reports enrollment of 85, and lists tricuspid valve insufficiency as the condition.

The described participants were indicated for tricuspid valve repair concomitantly with left-sided heart surgery. Implantation was considered appropriate by the surgeon for patients in the described arm. The listed interventions are tricuspid valve repair, left-sided heart surgery, and the Contour 3D Tricuspid Annuloplasty Ring. The record identifies an implanted cohort for the primary outcome.

The study title calls the assessment expertise-based, but the registry record does not report further details about how expertise shaped treatment selection or study conduct. Allocation is not stated. This is not a randomized comparison, and the described arms are not a like-for-like control comparison. As a result, the study design described in the registry is suited to recording outcomes in the treated cohort, not to isolating a comparative treatment effect against a control arm.

The study started in 2011-01, had primary completion in 2016-01, and has COMPLETED status. The primary endpoint timeframe includes baseline, discharge up to 5 days post-implant, and 6 months post-implant. The record also lists 8 outcome measures and names several secondary outcome domains. Numerical primary and secondary endpoint results are not reported in the registry record.

The registry record does not report a protocol-level account of eligibility criteria beyond the described arm, the number of sites, the approach to follow-up, or the statistical analysis plan. These omissions limit how fully the design and its execution can be evaluated from the record alone.

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:

Analysis population for the primary outcome, as defined in the registry: Implanted cohort

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: Baseline data include all subjects who underwent the implant procedure of the study device

6. Primary Endpoint

The registry lists the primary outcome as Mean Gradient Across the Tricuspid Valve, measured over At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant.

The primary endpoint is the mean gradient across the tricuspid valve, measured by echocardiography and expressed in mmHg. It is listed as a mean with standard deviation, and the primary population is the implanted cohort. Measurements are specified at baseline, discharge up to 5 days after implantation, and 6 months after implantation.

In general, a pressure gradient describes a difference in pressure across a valve during blood flow. An echocardiographic gradient is used as a hemodynamic measure: it characterizes flow-related pressure across the valve rather than directly measuring the device or the operation. Reporting the mean describes the cohort’s average measurement, while the standard deviation describes how dispersed individual measurements are around that average.

Measurements at more than one time point can describe how the cohort’s recorded values vary over follow-up. Interpretation depends on the actual values, the number of participants measured at each time, and the uncertainty around the estimates. Those numerical endpoint results and the corresponding analysis details are not reported in the registry record, so the direction, size, and precision of any change cannot be assessed from the information reported.

The endpoint is relevant to the study’s stated aim of assessing hemodynamic performance after repair. It does not, on its own, establish a comparative effect, explain the cause of a measurement, or summarize every aspect of clinical outcome. The registry also lists structural and functional secondary outcomes, but numerical findings for those outcomes are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous measure. The registry describes it as a mean with standard deviation, in mmHg, at baseline, discharge up to 5 days post-implant, and 6 months post-implant. The following concepts are general explanations of how such summaries are commonly understood; they do not establish which additional methods were used in this study.

What does a mean describe?

For a continuous measurement, the mean is an average across the observed participants. It provides a concise description of the cohort’s central value, but it does not show the full distribution. Participants may have measurements close to the mean or spread widely around it. The standard deviation describes that spread in the observed measurements. It is not the same as the uncertainty of the estimated mean: that uncertainty also depends on how many observations contribute and on the analysis method.

The registry gives the endpoint’s summary type but does not provide the numerical mean or standard deviation at any time point. It also does not report the number of endpoint observations contributing at baseline, discharge, or 6 months. Without these details, it is not possible to describe the distribution or the precision of the cohort’s mean from the record.

How should repeated measurements be viewed?

Measurements at baseline and follow-up can be summarized at each time point or analyzed as within-participant changes. A change analysis uses the relationship between measurements from the same participant; an analysis of separate time-point summaries may not make the same use of that relationship. Repeated measurements also require attention to participants who lack one or more follow-up observations. The registry specifies the measurement times, but the analysis approach for repeated measurements is not reported in the registry record.

The registry names changes from baseline through 6 months for right ventricle diastolic area, tricuspid annular diameter measured at diastole, right ventricle fractional area, and NYHA classification. It does not provide numerical results for these outcomes in the record information. The method used to analyze each measure, including whether a change score or another approach was used, is not reported in the registry record.

What does a confidence interval contribute?

In general, a confidence interval presents a range of estimates compatible with the observed data under a specified statistical method. It communicates uncertainty around an estimate and is usually more informative about precision than a point estimate alone. It does not mean that there is a particular probability that the fixed underlying value lies inside the interval. The width and interpretation depend on the data and method. Confidence intervals for the primary endpoint are not reported in the registry record.

What does a p-value contribute?

In general, a p-value measures how unusual data at least as extreme as those observed would be under a specified statistical model and null hypothesis. It does not measure the size or clinical importance of an effect, nor does it establish that an effect is present or absent. Its interpretation depends on the analysis plan, the hypothesis tested, and the assumptions used. A primary endpoint p-value and the analysis details needed to interpret one are not reported in the registry record.

Why does the comparison structure matter?

Random allocation, when used, is intended to make treatment groups comparable on average with respect to factors that could affect outcomes. The registry record does not state an allocation method and identifies the study as not a randomized comparison. It also cautions that the arms are not a like-for-like control comparison. Therefore, the design does not support interpreting a difference between arms as an unbiased treatment contrast. The arm description instead concerns participants receiving repair with the ring when the surgeon considered implantation most appropriate.

For an uncontrolled treated cohort, a before-and-after pattern can describe observed measurements over time, but it cannot separate the contribution of the device from the contribution of the accompanying left-sided heart surgery or other changes over follow-up. This is a general limitation of interpreting temporal changes without a suitable comparator, not a claim about the direction or size of any change in this study.

What do the planning assumptions mean?

The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and use of a normal approximation. They describe the effect to detect as a stated fraction of the observed effect. In general, a sample-size calculation combines an assumed effect with assumptions about variability, error rates, allocation, and the analysis to estimate the number of participants needed for a target design. A planning count is not the number actually analyzed and is not an estimate of achieved power after the results are known.

The record describes planning illustrations based on the observed effect; these are not the trial’s own design justification. No planning counts or observed primary effect estimates are reported in the registry record. The planning assumptions therefore cannot be used to infer the enrollment rationale or the precision of the posted endpoint findings. The registry does not report the trial’s sample-size justification or a detailed statistical plan.

Why can over-dispersion matter?

In general, over-dispersion means that variability in the data exceeds what a chosen statistical model assumes. When a model understates variability, standard errors and uncertainty intervals may be too small, and tests can appear more decisive than warranted. Methods that account for over-dispersion may be appropriate for some data structures. The primary endpoint is a continuous measurement summarized by a mean and standard deviation; the registry does not report an over-dispersion assessment or model-based analysis for it. This general concept should not be mistaken for a reported issue in this study.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Baseline", "Discharge (up to 5 Days Post-implant)", "6 Months Follow-Up")
n   <- c(45, 57, 58)
m   <- c(1.3, 2, 1.9)
sp  <- c(0.6, 1, 0.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Baseline  45  1.300  0.600  1.120  1.480
CARM  Discharge (up to 5 Days Post-implant)  57  2.000  1.000  1.735  2.265
CARM  6 Months Follow-Up  58  1.900  0.900  1.663  2.137

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures, including the primary mean gradient endpoint and secondary measures concerning right ventricle diastolic area, tricuspid annular diameter, right ventricle fractional area, and NYHA classification. When a study assesses multiple outcomes or multiple time points, there may be more opportunities for chance findings. In general, multiplicity methods can control the overall chance of false-positive conclusions or define a hierarchy of outcomes. The registry record does not report whether any multiplicity adjustment or testing hierarchy was planned.

Numerical findings for the primary endpoint and the named secondary outcomes are not reported in the registry record. The record also lists 0 analyses. It does not provide p-values, confidence intervals, or detailed analysis specifications that would clarify how outcomes and time points were evaluated. Without those details, neither the statistical significance nor the precision of the endpoint findings can be assessed from the registry information.

Missing-data handling is also not reported in the registry record. The primary endpoint population is the implanted cohort, but the number with measurements at each scheduled time is not reported. Although enrollment is 85, the safety risk sets are 76 for both serious and other adverse events. The record does not explain the difference between enrollment and those risk sets, or report reasons for missing observations, withdrawals, or exclusions from endpoint analyses. No particular missing-data mechanism or method should be inferred.

In general, missing data can affect both the number of observations and the representativeness of the analyzed participants. A complete-case summary, for example, describes those with the relevant measurements, while other approaches rely on additional assumptions. Which approach was used is not reported in the registry record. The analysis population for the secondary outcomes and the handling of repeated measurements are also not reported.

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: haemorrhage (15.8%), atrioventricular block, complete (13.2%), respiratory failure (11.8%), bradycardia (7.9%), acute kidney injury (6.6%).

Within 6 months of the implant procedure, the registry reports 45 of 76 participants affected by serious adverse events and 46 of 76 affected by other adverse events. It reports 3 deaths. These are separate summary figures; the record does not state whether the participant groups overlap, how events were attributed, or the event-counting rules used. The figures should therefore be read as registry summaries, not as a comparison between treatments or as evidence of causation.

The listed serious adverse event terms and percentages are Haemorrhage, 15.8%; Atrioventricular Block, Complete, 13.2%; Respiratory Failure, 11.8%; Bradycardia, 7.9%; Acute Kidney injury, 6.6%; and Pleural Effusion, 6.6%. The registry information does not specify the denominator or counting convention for each listed percentage, so these values should not be converted into participant counts or interpreted as risks beyond their stated presentation.

The safety window is within 6 months of the implant procedure. The risk sets are 76 for both serious and other adverse events, while total enrollment is 85. The reason for this difference is not reported in the registry record. The record does not state whether the deaths were considered related to the device or procedure, and no causal relationship should be inferred from the event summaries alone.

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

The record establishes that a completed post-market study evaluated the Contour 3D Tricuspid Annuloplasty Ring in the setting of tricuspid valve repair performed with left-sided heart surgery. It identifies a primary echocardiographic outcome, gives its measurement times and units, names secondary outcome areas, and provides a summary of adverse events. These details clarify what the registry intended to assess and which safety window it recorded.

The record does not provide numerical primary endpoint findings. It therefore does not show the mean gradient at baseline, discharge, or 6 months, nor the magnitude or precision of change over time. Numerical results for the named secondary outcomes are also not reported in the registry record. Without those results, the direction and size of the observed endpoint patterns cannot be described.

The study is not a randomized comparison, allocation is not stated, and the described arms are not a like-for-like control comparison. Thus, the record cannot support a causal comparison between the ring and another treatment. Even if cohort measurements changed over follow-up, a change alone would not identify which component of care caused it. The intervention occurred alongside left-sided heart surgery, and the record does not describe a concurrent control group that could address this limitation.

The safety figures describe events recorded within 6 months, including serious and other adverse events and deaths. They do not establish that the device or procedure caused an event. The registry record does not report event attribution, the reason the safety risk sets differ from enrollment, or enough detail to resolve how event terms and percentages were counted.

In general, registry summaries are most informative when read alongside endpoint estimates, uncertainty intervals, analysis populations, missing-data methods, and a prespecified analysis plan. Several of these details are not reported in the registry record. The available information supports a cautious account of study purpose, design, outcome definitions, and recorded safety summaries, but does not allow a judgment about the magnitude or comparative interpretation of clinical outcomes.

14. Why This Trial Matters Statistically

This study is statistically notable because it concerns a device evaluated after market release, in a setting where the registry frames the objective as assessment of hemodynamic performance. Post-market evaluations can describe how measurements and safety events are recorded in a clinical cohort. Their interpretation still depends on the quality and completeness of outcome reporting, the analysis population, and the presence or absence of a suitable comparison.

The primary endpoint is continuous and measured at baseline and follow-up. This makes the distinction between a cohort mean, the spread of individual values, and the uncertainty around an estimated mean important. The registry identifies the mean and standard deviation as the summary form, but numerical estimates are not reported in the registry record. The timing of measurements is defined, yet the record does not provide endpoint-specific observation counts or an analysis of within-participant change.

The nonrandomized design also matters. The record does not state allocation and does not describe a like-for-like control comparison. A treated cohort can provide descriptive information, but without a suitable comparator it cannot isolate the device’s contribution from other aspects of care or from change over time. This is a design constraint, not a claim that the study’s measurements had any particular direction.

Finally, the registry’s broad outcome listing and safety summary sit alongside missing analysis details. Multiplicity procedures, missing-data methods, and a detailed statistical plan are not reported in the registry record. The safety summary gives participant counts and named serious event terms, but does not establish causality. These distinctions are central to reading post-market evidence carefully: a clear study question and a completed status do not substitute for numerical endpoint results and transparent methods.

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 limitation for interpreting efficacy-related findings is that numerical endpoint results are not reported in the registry record. The record specifies the mean gradient, its unit, summary type, population, and measurement times, but does not report the measured values, standard deviations, changes, confidence intervals, or p-values. Numerical results for the named secondary outcomes are also not reported.

The study is not a randomized comparison, allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. The described arm concerns patients undergoing tricuspid valve repair concomitantly with left-sided heart surgery, with ring implantation considered appropriate by the surgeon. The record therefore does not offer a controlled contrast that would isolate the device’s contribution.

Enrollment is reported as 85, whereas the serious and other adverse-event risk sets are each 76. Reasons for this difference, and the number of participants with primary endpoint measurements at each follow-up time, are not reported in the registry record. Missing-data handling, participant flow, and analysis populations beyond the implanted cohort description are also not reported.

The registry lists 8 outcome measures, but multiplicity handling and the detailed statistical analysis plan are not reported. The planning assumptions describe an illustrative calculation based on a fraction of the observed effect, but planning counts and the observed effect are not reported in the registry record. The sample-size justification for the trial is not reported.

Safety information is limited to the stated 6-month window, affected-participant summaries, deaths, and listed serious event terms with percentages. The record does not report event attribution, event-counting conventions, or the basis for the listed percentages. These limitations restrict assessment of precision, completeness, and causality.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty — NCT01532921.
• Registry record last updated 2018-08-10; status last verified 2017-11.
• Results first posted 2018-08-10.
• 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

EASE TRICUSPID is a completed post-market study sponsored by Medtronic Cardiac Rhythm and Heart Failure, with enrollment of 85. It evaluated the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following tricuspid valve repair performed with left-sided heart surgery. The primary endpoint is the echocardiographic mean gradient across the tricuspid valve in the implanted cohort, assessed at baseline, discharge up to 5 days post-implant, and 6 months post-implant.

The registry names secondary outcomes involving right ventricle area and fractional area, tricuspid annular diameter, and NYHA classification. It reports safety summaries within 6 months, including 45 of 76 participants affected by serious adverse events, 46 of 76 affected by other adverse events, and 3 deaths. Numerical primary and secondary outcome findings, detailed analysis methods, missing-data handling, and event attribution are not reported in the registry record. The study is not a randomized comparison, and allocation is not stated.