The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance (NCT01732835), a na na study. The primary outcome is Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.

2. Clinical Question

The question is descriptive: it concerns the observed course of participants who received the device, rather than whether the device performs differently from another repair method. Secondary outcomes address procedure success, cardiovascular events, survival at 2 years, aortic insufficiency, functional capacity, and change in peak gradient. These outcomes broaden the description of follow-up, but do not create a controlled comparison.

The registry describes a prospective, non-randomized, multi-center investigation. Prospective follow-up can organize assessment around planned time points, while multiple centers can include experience from more than one setting. Those features do not, by themselves, establish how participants were selected, how outcomes were assessed, or whether the enrolled group represents a wider population. Such details are not reported in the registry record.

3. Trial Design

This is a completed, prospective, non-randomized, multi-center, single-group device trial. Its intervention is implantation of the HAART 300 annuloplasty device for aortic valve repair. The registry lists 68 participants enrolled, allocation as NA, and masking as none. The record identifies Biostable Science & Engineering as sponsor. The study concerns aortic insufficiency and evaluates the device’s extended safety and performance.

Because the trial has one group and no randomized allocation, the central evidence is the observed experience after implantation. It does not directly compare outcomes with those under another device, a different surgical approach, or no device. Differences from an outside population or from historical experience would not be randomized comparisons and would require information not reported in the registry record.

The registry lists the study start as 2012-12 and primary completion as 2014-06, with status completed. The primary endpoint is survival free from all-cause death at 6 months postprocedure. Listed secondary outcomes include implant procedure success; actuarial freedom from clinical cardiovascular events; survival free from all-cause death at 2 years; aortic insufficiency at 2 years; New York Heart Association functional capacity classification at 6 months and 2 years; and peak-gradient change from baseline. Peak-gradient change appears twice in the registry’s outcome list.

The registry does not report detailed eligibility criteria, center names, participant characteristics, surgical details, follow-up completeness, or outcome-assessment procedures. It also does not report a protocol or a statistical analysis plan. Enrollment alone does not establish how many participants contributed data to each endpoint; endpoint-specific analysis populations are not reported in the registry record.

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.

6-month Primary Endpoint

Reasons for not completing this period:

2-year Extended Follow-up

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Participants with implanted device

6. Primary Endpoint

The registry lists the primary outcome as Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure, measured over 6 months.

The primary safety outcome is survival free from all-cause death at 6 months postprocedure, expressed as a percentage of participants. It describes the proportion meeting a clearly specified status at a follow-up time: alive and not having experienced death from any cause by that point. The registry identifies a 95% confidence interval as the measure of dispersion for this percentage.

All-cause death includes deaths regardless of their cause. As a general statistical concept, this definition avoids requiring attribution of a death to the device or procedure, which can be difficult to determine consistently. The endpoint is therefore a broad safety measure, not a direct measure of device-specific causation or of every aspect of valve function.

A confidence interval communicates uncertainty around an estimated percentage. In general, it reflects the range of values compatible with the observed data under the method used; it is not a guarantee that the true value lies within that range. The registry record does not report the endpoint’s percentage, confidence interval, number of deaths, or number assessed at 6 months. Consequently, the outcome’s observed level and precision cannot be evaluated from the reported information.

The choice of a six-month endpoint also defines the time horizon of the primary question. It does not, on its own, establish longer-term survival or performance. Although survival at 2 years is listed as a secondary outcome, its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a percentage outcome and a 95% confidence interval for the primary endpoint. It does not report the statistical method used to calculate that interval, the observed percentage, the number of deaths, or the number contributing to the analysis. The following explains the relevant concepts generally; it does not identify methods as having been used in this trial unless the registry explicitly names them.

What does a percentage outcome represent?

As a general statistical concept, a percentage for a binary outcome summarizes how many participants meet a defined condition among those assessed. Here, the condition is being alive without all-cause death at 6 months postprocedure. The denominator matters: an estimate based on everyone enrolled may differ from one based only on participants with recorded follow-up. The registry lists enrollment of 68 but does not report the primary endpoint’s denominator, so the analysis population cannot be identified from the record.

A percentage is descriptive, not a causal comparison. In this single-group design, it would characterize the observed participants. To estimate a difference between treatment strategies, a suitable comparison group and an analysis that accounts for the design would be needed. This trial has no like-for-like control group in the registry record.

What does a confidence interval add?

In general, a confidence interval expresses the statistical uncertainty associated with an estimate. A narrower interval indicates greater precision under the method’s assumptions, while a wider interval indicates less precision. The interval does not correct for selection, missing follow-up, measurement problems, or lack of a comparator. The registry specifies a 95% confidence interval but reports neither its bounds nor the calculation method. Its precision therefore cannot be assessed.

Confidence intervals also require careful interpretation. A 95% interval is not a probability statement that the particular interval contains the true value. It describes the long-run performance of a method under its assumptions. Those assumptions and the method used for this endpoint are not reported in the registry record.

How does the design affect statistical interpretation?

In general, random allocation helps make comparison groups similar, on average, with respect to both measured and unmeasured characteristics. This trial is non-randomized and single-group, so that mechanism is absent. Descriptive follow-up can record outcomes after implantation, but it cannot separate treatment effects from other explanations using an internal randomized comparison. The registry’s designation of masking as none also means the record does not describe blinded outcome assessment; how outcomes were assessed is not reported.

The study is prospective and multi-center according to the registry. Generally, prospective outcome collection can define follow-up in advance, while participation across centers may reflect more than one clinical setting. Neither feature guarantees complete data, consistent measurement, or broad representativeness. Center-specific methods and the process for handling differences across centers are not reported.

What do the listed follow-up outcomes contribute?

The secondary outcomes cover different kinds of information. Procedure success and clinical cardiovascular events concern procedural or clinical status; survival and aortic insufficiency address later outcomes; functional capacity classification and peak-gradient change address other aspects of follow-up. These are distinct outcomes and should not be treated as interchangeable evidence. The registry lists them but does not report their results, definitions beyond their titles, analysis methods, or endpoint-specific participant counts.

For change from baseline, a general analysis may compare follow-up measurements with baseline values, but the registry does not specify whether the trial used such a comparison, how measurements were summarized, or how missing measurements were handled. The repeated listing of peak-gradient change does not establish that two different analyses were conducted.

What can be said about planning calculations?

The record’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The record explicitly distinguishes this illustration from the trial’s own design. It is not evidence that this single-group trial randomized participants between two arms, nor does it establish the original enrollment rationale. The trial’s sample-size justification is not reported in the registry record. Planning illustrations are not observed power and do not substitute for a reported outcome estimate and confidence interval.

More generally, a sample-size calculation depends on assumptions about the effect to detect, variability or event frequency, statistical error rates, and design. If assumptions differ from observed conditions, the planning calculation may not describe the achieved precision. No numerical sample-size outputs are included in the record information for interpretation.

What analysis details remain unknown?

The registry reports zero analysis entries. It does not identify a statistical model, adjustment variables, handling of censoring, rules for the analysis population, missing-data procedures, or an approach to multiple outcomes. These details can affect estimates and uncertainty. Their absence from the registry record means they cannot be reconstructed from the outcome titles or study design. No recalculated outcome estimates are reported in the record information.

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("HAART 300 Annuloplasty Device")
n      <- c(49)
events <- c(49)
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  HAART 300 Annuloplasty Device  49  49  100.0  92.7  100.0  92.7  100.0  92.9  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary safety outcome and multiple secondary outcomes. Considering several outcomes raises the general issue of multiplicity: the more statistical questions examined, the greater the chance that some results may appear notable by chance if each is judged separately. Whether this issue was addressed depends on a prespecified analysis strategy, such as prioritizing outcomes or adjusting inference. Such a strategy is not reported in the registry record. No inferential results are available to assess.

The registry records zero analysis entries. It does not report whether outcomes were tested, whether any adjustment was planned, how secondary outcomes were ordered, or whether subgroup analyses were conducted. The presence of multiple outcome listings alone does not establish that formal hypothesis tests were performed.

Missing-data handling is also not reported. The total enrollment is 68, but the number assessed for the primary outcome and each secondary outcome is not given. As a general principle, missing follow-up can affect an estimate when the participants without data differ from those with data in ways related to the outcome. The extent and direction of any such influence cannot be evaluated without denominators, reasons for missingness, and the analysis approach.

Analysis populations are not described. The registry does not specify whether analyses included all enrolled participants, only those who received the device, or another defined group. It also does not explain how withdrawals, incomplete follow-up, or protocol deviations were handled. These omissions limit assessment of both the estimates and their generalizability.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 4% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: aortic insufficiency (10.2%), arrhythmia (8.2%), pericardial effusion (8.2%), pneumothorax (6.1%), pleural effusion (4.1%).

The registry lists the HAART 300 device group with 49 participants at risk for serious adverse events and 23 affected. For other adverse events, it lists 49 at risk and 38 affected. These are the registry’s reported counts; the record information does not clarify the participant-level event definitions or how multiple events in one person were handled.

The listed serious adverse-event terms and percentages are aortic insufficiency, 10.2%; arrhythmia, 8.2%; pericardial effusion, 8.2%; pneumothorax, 6.1%; pleural effusion, 4.1%; and angina pectoris, 2.0%. These percentages should be read as reported for the terms, not added together: one participant may have experienced more than one event, and the record does not explain overlap or provide term-specific counts.

Adverse-event reporting describes events recorded during a study; it does not establish that the device caused them. The registry record does not report event timing, severity criteria beyond the serious-event classification, attribution rules, or comparison-group rates. Because this is a single-group trial, the listed figures do not provide a randomized estimate of excess risk relative to another treatment.

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

The study’s stated purpose is to evaluate extended safety and performance of the HAART 300 annuloplasty device when used in surgical aortic valve repair. Its registry entry documents a prospective, non-randomized, multi-center, single-group investigation with 68 participants enrolled. It identifies survival free from all-cause death at 6 months as the primary outcome and lists a range of secondary outcomes covering procedure success, cardiovascular events, survival, valve insufficiency, functional status, and peak gradient.

Those design and outcome details describe what the study set out to evaluate. They do not communicate the observed primary result. The percentage surviving free from all-cause death at 6 months and its 95% confidence interval are not reported in the registry record. The listed secondary outcome results are also not reported in the registry record. Therefore, the record does not support a conclusion about the measured level of the primary outcome or the precision of its estimate.

Even if a single-group outcome estimate were available, its interpretation would remain descriptive. Without a control group, observed outcomes cannot be directly attributed to the device or compared fairly with outcomes under another strategy. Non-randomized follow-up can be informative about the experience recorded in the enrolled group, but factors other than the intervention may also influence outcomes.

The safety information lists affected participants and serious-event terms, but does not establish causation. It also does not provide all the detail needed to assess event overlap, timing, attribution, or comparative risk. Similarly, enrollment does not tell readers how complete follow-up was for each outcome.

Accordingly, the registry entry establishes the study’s design, enrollment, primary endpoint, and some reported adverse-event information. It does not provide enough outcome or analysis detail to judge the primary endpoint’s magnitude, statistical precision, or comparative meaning. The absence of a reported result should not be mistaken for a favorable or unfavorable finding.

14. Why This Trial Matters Statistically

This trial is statistically instructive because its central question and design are not the same as those of a controlled comparison. It asks about survival free from all-cause death after implantation in a single group. The design can describe observed follow-up, but it cannot estimate a randomized contrast between the device and another strategy. Recognizing that distinction prevents a descriptive percentage from being mistaken for evidence of comparative effect.

The registry also shows why the endpoint definition and its uncertainty matter. Naming a six-month survival outcome makes the time horizon and event of interest clear. Naming a 95% confidence interval indicates that precision was intended to accompany the percentage. But without the estimate, interval, and denominator, readers cannot assess either the outcome level or its precision. An endpoint description is not a result.

The range of secondary outcomes illustrates another general issue: safety and performance are multidimensional. Survival, adverse events, valve insufficiency, functional capacity, and peak-gradient change represent different aspects of follow-up. Their presence in a registry does not imply that results were reported or that one measure can stand in for another. Clear outcome reporting requires results and analysis populations for each measure.

Finally, the entry distinguishes the trial’s design from a planning illustration that assumes equal allocation between two arms. A planning assumption is not evidence that the actual study had those arms; the registry describes a single group. This distinction matters because design assumptions determine what a statistical calculation can answer. The study’s own sample-size justification and statistical analysis plan are not reported in the registry record.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpreting outcomes is that the registry record does not report the primary endpoint result, its confidence interval, or its analysis denominator. Although survival free from all-cause death at 6 months is clearly identified, its observed value and precision cannot be assessed. Results for the listed secondary outcomes are likewise not reported in the registry record.

The single-group, non-randomized design limits causal and comparative interpretation. There is no concurrent control group, and allocation is listed as NA. The record therefore cannot provide a randomized comparison with another device or approach. Masking is listed as none, while procedures for outcome assessment are not described.

Enrollment is reported as 68, but endpoint-specific follow-up counts and completeness are not. Eligibility criteria, baseline participant characteristics, center-level information, and detailed procedural descriptions are not reported in the registry record. Without these details, readers cannot fully assess who was studied, how consistently outcomes were measured, or how representative the participants may be.

The registry lists serious adverse-event counts and selected event-term percentages, but does not report timing, attribution procedures, term-specific counts, or whether participants could contribute to multiple terms. The figures therefore provide limited context for assessing safety and cannot establish causation or comparative risk.

Finally, the record does not report the statistical analysis plan, missing-data methods, analysis populations, multiplicity approach, or sample-size justification. The registry’s planning illustration is not the study’s design. These omissions prevent assessment of how analyses were conducted and whether the reported outcomes, if available elsewhere, would align with prespecified methods.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance — NCT01732835.
• Registry record last updated 2017-03-10; status last verified 2017-01.
• Results first posted 2017-01-31.
• 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

NCT01732835 is a completed, prospective, non-randomized, multi-center, single-group trial of the HAART 300 annuloplasty device for surgical aortic valve repair in participants with aortic insufficiency. The registry lists 68 participants enrolled, allocation as NA, and masking as none. The sponsor is Biostable Science & Engineering.

The primary safety outcome is survival free from all-cause death at 6 months postprocedure, expressed as a percentage with a 95% confidence interval. The registry record does not report its numerical result or confidence interval. Secondary outcomes include procedural success, cardiovascular events, survival at 2 years, aortic insufficiency, functional capacity, and peak-gradient change.

The record lists adverse-event information for 49 participants at risk, including 23 affected by serious adverse events, and provides percentages for selected serious-event terms. Detailed analysis methods, missing-data handling, and endpoint-specific analysis populations are not reported in the registry record.