This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for HeartMate 3 CE Mark Study Long Term Follow-up (NCT03022461), a registered phase not stated study. The primary outcome is Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03022461 |
| Phase | Phase not stated |
| Condition | Advanced Refractory Left Ventricular Heart Failure |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Abbott Medical Devices |
| Results posted | Yes |
2. Clinical Question
The registry record concerns patients with advanced refractory left ventricular heart failure who had received the HeartMate 3 LVAS in the CE Mark Study and continued using the device after its 2-year follow-up. The long-term investigation was intended to report survival and adverse events among patients who consented to continued data collection. It was not designed as a randomized comparison of HeartMate 3 against another device or treatment.
Population
Ongoing HeartMate 3 CE Mark Study patients who consented to long-term follow-up data collection. The condition listed is advanced refractory left ventricular heart failure. The registry enrollment is 25.
Intervention
The investigation follows patients who continue with the HeartMate 3 LVAS after the CE Mark Study 2-year follow-up. The listed intervention is long-term follow-up, rather than a newly assigned treatment.
Comparator
No comparison group is described. The study is single arm, non-randomized, and non-blinded, so its findings cannot provide a like-for-like estimate of outcomes relative to a control group.
Primary question
What percentage of patients survived at 5 years post HM3 CE Mark study implant, and what was the associated 95% confidence interval? The registry record states this endpoint and timeframe but does not report the survival estimate or its interval.
Secondary outcomes include the EuroQoL 5D-5L VAS Score, Six Minute Walk Test, New York Heart Association classification, adverse events, device malfunctions, reoperations, rehospitalizations, and survival without a debilitating stroke, defined as MRS >3. These outcomes describe different aspects of health status, function, and safety; their inclusion does not mean that results for each are available in the registry record.
3. Trial Design
This is a prospective, multicenter, single-arm, non-blinded, non-randomized long-term follow-up study. Its stated purpose is to report survival and adverse events among patients implanted with HM3 in the CE Mark Study who remained ongoing with the HeartMate 3 LVAS after that study's 2-year follow-up. Continued participation depended on consent to long-term data collection.
The registry enrollment is 25. The study start date is 2014-06-23, its primary completion date is 2019-12-12, and its status is COMPLETED. Abbott Medical Devices is the sponsor. The named study population is ongoing HM3 CE Mark Study patients; no separate control arm is described.
The design is observational with respect to the long-term follow-up question: the record describes monitoring patients who continued with the device, not random assignment to treatment groups. Non-blinding means that the investigation was not described as blinded. The registry record does not report the procedures used to assess outcomes or whether any outcome assessments were blinded.
Because there is no comparator arm, the design can describe outcomes observed in the followed group but cannot isolate the effect of the device from other influences. Continued participation and consent also define who contributed to this follow-up; the registry record does not report how those who did not continue differed from those who did. The record does not state a separate recruitment procedure, follow-up schedule for each outcome, or detailed eligibility criteria beyond the description of ongoing CE Mark Study patients who consented.
The study lists 9 outcome measures, but the registry record reports 0 analyses. Completion status therefore should not be taken as evidence that numerical results for each listed measure are available in the 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.
Overall Study
| Stage | Ongoing HM3 CE Mark Study Patients |
|---|---|
| STARTED | 25 |
| COMPLETED | 22 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Ongoing HM3 CE Mark Study Patients |
|---|---|
| Death | 3 |
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.
| Characteristic | Unit | Ongoing HM3 CE Mark Study Patients |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | years | 59.9 (SD 13.2) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 21 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Canada | participants | 2 |
| Region of Enrollment: Austria | participants | 2 |
| Region of Enrollment: Czechia | participants | 7 |
| Region of Enrollment: Kazakhstan | participants | 4 |
| Region of Enrollment: Australia | participants | 1 |
| Region of Enrollment: Germany | participants | 9 |
| Body Surface Area (BSA) | m^2 | 2.0 (SD 0.2) |
| Body Mass Index (BMI) | kg/m^2 | 27.3 (SD 4.7) |
| Ischemic Etiology | Participants | 11 |
| Indication for Left Ventricular Assist Device (LVAD) implant: Bridge to cardiac transplantation (BTT) | Participants | 14 |
| Indication for Left Ventricular Assist Device (LVAD) implant: Permanent destination therapy (DT) | Participants | 11 |
| INTERMACS Profile: Profile 1 | Participants | 0 |
| INTERMACS Profile: Profile 2 | Participants | 1 |
| INTERMACS Profile: Profile 3 | Participants | 9 |
| INTERMACS Profile: Profile 4 | Participants | 14 |
| INTERMACS Profile: Profile 5 | Participants | 1 |
| INTERMACS Profile: Profile 6 | Participants | 0 |
| INTERMACS Profile: Profile 7 | Participants | 0 |
| Cardiac Index | l/min/m^2 | 1.7 (SD 0.34) |
| Left Ventricular Ejection Fraction (LVEF) | percentage | 19.4 (SD 3.7) |
| Central Venous Pressure (CVP) | mmHg | 9.3 (SD 5.01) |
| Arterial Blood Pressure: Systolic pressure | mmHg | 105.3 (SD 11.7) |
| Arterial Blood Pressure: Mean pressure | mmHg | 77.5 (SD 8.6) |
| Arterial Blood Pressure: Diastolic pressure | mmHg | 23.1 (SD 9.5) |
| Pulmonary Artery Pressure: Systolic | mmHg | 51.8 (SD 20.8) |
| Pulmonary Artery Pressure: Mean | mmHg | 33.7 (SD 13.3) |
| Pulmonary Artery Pressure: Diastolic | mmHg | 23.1 (SD 9.5) |
6. Primary Endpoint
The registry lists the primary outcome as Survival, measured over At 5 years post HM3 CE Mark study implant.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of patients who survived |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is survival, expressed as the percentage of patients who survived at 5 years post HM3 CE Mark study implant. It is a clinically interpretable summary of whether patients were alive at a defined follow-up landmark. The record describes the outcome more broadly as subject outcomes and survival over time, while specifying the five-year point for the primary measure.
The registry record also identifies a 95% confidence interval as the dispersion measure. In general, a confidence interval conveys the precision of an estimate: a narrower interval indicates greater precision under the statistical method used, while a wider interval indicates more uncertainty. Its interpretation depends on the method and assumptions used to calculate it.
The registry record does not report the percentage surviving, the confidence-interval limits, or the method used to estimate them. It therefore does not permit a numerical assessment of survival at the specified time point. The endpoint description alone is not a result, and no survival comparison with another treatment can be made from this single-arm record.
Survival can also be analyzed as a time-to-event outcome, which uses information about when deaths occur and how long patients are observed. In general, that approach can account for differing follow-up times through censoring methods. The record does not state whether such a method was used, so it should not be assumed that the primary endpoint was estimated with a particular time-to-event procedure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a five-year survival endpoint and a 95% confidence interval, but it does not report the survival estimate or interval. That distinction is central: the stated outcome defines what the investigation intended to measure, but it does not establish the observed result. The record also lists 0 analyses, so no inferential result for the primary endpoint is available for interpretation.
The adverse-event summary reports 25 at risk and 13 affected for serious events, and 25 at risk and 0 affected for other events. It also records 3 deaths. These are descriptive entries in the registry record; they do not, by themselves, provide event timing, exposure-adjusted rates, or a comparison with another group. The reported counts should not be treated as a causal estimate of device-related risk.
The listed serious adverse-event terms and percentages are Infection, 36.0%; Other Adverse Event, 32.0%; Bleeding, 12.0%; Stroke, Hemorrhagic, 12.0%; Stroke, Ischemic, 8.0%; and Outflow Graft Thrombosis, 8.0%. The record does not explain the denominator or counting basis for these percentages, nor whether a patient could contribute to more than one category. They should therefore be read as the registry's reported category summaries, not as mutually exclusive shares or as rates calculated over person-time.
The study's single-arm, non-randomized design limits interpretation of outcomes as treatment effects. Without a concurrent comparator, the observed experiences cannot show what would have happened to similar patients under another treatment or without the device. The record also identifies a population selected from patients who completed the earlier CE Mark Study follow-up and consented to continue. This follow-up population may not represent all patients who received HM3 in that study.
Secondary outcomes include quality of life, walking performance, functional classification, adverse events, device malfunctions, reoperations, rehospitalizations, and survival without a debilitating stroke. The registry record lists these measures but does not provide numerical results for them. Their presence in the outcome list should not be interpreted as evidence that they improved, worsened, or were fully observed.
Overall, the record describes the research question, design, and some adverse-event summaries, but it does not supply the primary survival estimate or analysis details. Conclusions should remain limited to those registry entries and should not extend to comparative effectiveness or causal attribution.
9. Statistical Methods Explained
The primary outcome is a percentage at a specified follow-up landmark, accompanied by a planned 95% confidence interval. In general, a percentage summarizes the proportion of an analyzed group meeting an outcome definition. To interpret it fully, readers need the numerator, denominator, outcome definition, and handling of incomplete follow-up. The registry record gives the endpoint description and study enrollment but does not report the primary survival numerator, analyzed denominator, estimate, or interval.
What does a confidence interval add?
In general, a confidence interval communicates statistical uncertainty around an estimate under a specified method and its assumptions. It is not a guarantee that the true value lies within the particular calculated interval, and it does not describe individual patient outcomes. The interval's width depends on factors such as the amount of outcome information and the method used. Here, the registry record names a 95% confidence interval but does not provide its limits or calculation method, so its precision cannot be assessed.
How might survival be analyzed?
In general, survival analysis can use the timing of events as well as the duration of follow-up. Patients who have not experienced the event by their last observed contact may be censored, meaning their later event status is unknown rather than assumed to be event-free indefinitely. Methods for estimating survival over time rely on assumptions about censoring and the completeness of follow-up. The registry record does not identify a survival estimator, censoring rule, or analysis population. It is therefore not possible to say which approach was used or whether the reported endpoint was based on a time-to-event analysis or a simple landmark proportion.
How should adverse-event summaries be read?
Adverse-event counts can describe how many participants were affected, how many events occurred, or both; those measures are not interchangeable. Recurrent events can occur in the same participant, and an event count can therefore exceed the number of affected participants. In general, event rates also require a measure of time at risk, while proportions require a clearly defined denominator. The registry record lists at-risk and affected counts for serious and other events and provides percentages for selected serious-event terms, but does not explain the category denominators, event recurrence, or exposure time. Those summaries should not be reinterpreted as rates.
In general, variation in event counts can be greater than a simple statistical model expects when events cluster within participants or when participants have differing underlying risks. This is often called over-dispersion. Methods that account for such variation may be relevant to analyses of recurrent events, but the record does not state that recurrent-event models were used. The concept is a general consideration, not a description of the study's reported analysis.
What do the planning assumptions mean?
The record describes sample-size planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event illustrations, the specified output is total events using the Schoenfeld approach; for other illustrations, it is participants per arm. These are planning assumptions, not evidence that the long-term follow-up study used a two-arm design. The study itself is single arm.
Such illustrations are hypothetical tools for planning a future comparison. They are not observed power, and they do not establish that a study had adequate power for its actual outcomes. The registry record reports 0 analyses and does not provide the observed effects needed to interpret concrete planning estimates. No actual sample-size illustration values are stated in the registry record.
The registry record does not report a statistical analysis plan, model specifications, covariate adjustments, hypothesis tests, or interim analyses. These omissions matter because the choice of method affects the estimate and its uncertainty. General statistical explanations can clarify what common methods do, but they cannot establish that those methods were used in this investigation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 9 outcome measures, including survival, quality of life, walking performance, functional classification, adverse events, device malfunctions, reoperations, rehospitalizations, and survival without a debilitating stroke. It reports 0 analyses. No outcome-specific numerical results, hypothesis tests, or adjusted comparisons are provided.
When a study assesses several outcomes, multiplicity can arise if many hypotheses are tested. In general, repeated testing can increase the chance of at least one apparently positive finding by chance. Statistical plans may address this through a prespecified hierarchy, adjustment, or by treating analyses as descriptive. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether any analyses were designated exploratory. No inference about the handling of multiplicity is possible.
Missing-data methods are also not reported. The record does not describe completeness of follow-up, reasons for missing observations, imputation, or sensitivity analyses. For survival outcomes, the treatment of censoring would be important; for other outcomes, the amount and pattern of missing measurements would affect interpretation. Neither can be assessed from the stated information.
The analysis population is not defined beyond the description of ongoing CE Mark Study patients who consented to continue long-term follow-up. The record does not state whether all enrolled patients were included in every outcome analysis or how deviations from follow-up were handled. It also does not specify whether an intention-to-treat, per-protocol, or other analysis population was used. These details are not reported in the registry record, so the analysis denominators cannot be established from the outcome descriptions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ongoing HM3 CE Mark Study Patients | 13 | 25 | 52.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ongoing HM3 CE Mark Study Patients | 3 of 25 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ongoing HM3 CE Mark Study Patients | 0 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | Ongoing HM3 CE Mark Study Patients |
|---|---|---|
| Infection | Infections and infestations | 9 of 25 |
| Other Adverse Event | Cardiac disorders | 8 of 25 |
| Bleeding | Vascular disorders | 3 of 25 |
| Stroke, Hemorrhagic | Nervous system disorders | 3 of 25 |
| Stroke, Ischemic | Nervous system disorders | 2 of 25 |
| Outflow Graft Thrombosis | Product Issues | 2 of 25 |
| Right Heart Failure | Cardiac disorders | 1 of 25 |
| Cardiac Arrhythmia | Cardiac disorders | 1 of 25 |
| Renal Dysfunction | Renal and urinary disorders | 1 of 25 |
| Other Neurological event | Nervous system disorders | 1 of 25 |
Serious events with the highest arm-level rate: infection (36.0%), other adverse event (32.0%), bleeding (12.0%), stroke, hemorrhagic (12.0%), stroke, ischemic (8.0%).
The adverse-event summary lists 25 at risk and 13 affected for serious events, alongside 25 at risk and 0 affected for other events. It also records 3 deaths. These entries describe the registry's reported counts; the record does not clarify how events were defined, whether participants could experience recurrent events, or how deaths relate to the adverse-event categories.
The serious-event terms are reported with these percentages: Infection, 36.0%; Other Adverse Event, 32.0%; Bleeding, 12.0%; Stroke, Hemorrhagic, 12.0%; Stroke, Ischemic, 8.0%; and Outflow Graft Thrombosis, 8.0%. The registry record does not state the denominator or counting basis for these percentages, or whether categories can overlap. They should not be added together or interpreted as mutually exclusive portions of a single total.
These summaries are not comparative safety estimates. No control group is described, and the record does not report exposure-adjusted rates or event timing. The entries also do not establish that an event was caused by the device. They describe the posted safety information without resolving those questions.
12. What the Result Does, and Does Not, Mean
The record establishes that long-term follow-up was intended for patients who remained on the HeartMate 3 LVAS after the CE Mark Study 2-year follow-up and consented to continued data collection. It identifies survival at 5 years post implant as the primary endpoint and specifies a 95% confidence interval. It also provides adverse-event summary counts and selected serious-event categories.
The record does not report the primary survival percentage or confidence interval, and it lists 0 analyses. It therefore cannot support a numerical conclusion about survival at the specified time point. The secondary outcome list likewise does not establish what happened to quality of life, walking performance, functional classification, device malfunctions, reoperations, rehospitalizations, or stroke-free survival, because outcome results are not reported.
The adverse-event entries provide descriptive information, but their interpretation is constrained by absent details about definitions, denominators for the listed percentages, event recurrence, timing, follow-up completeness, and exposure time. The counts cannot be converted into comparative risk estimates using information in the registry record, and they do not establish causality.
More broadly, this is a single-arm, non-randomized follow-up investigation rather than a randomized comparison. Its observations cannot determine whether outcomes differ from those under another treatment, nor separate the influence of the device from other clinical or patient factors. The participants were also those who continued from the CE Mark Study and consented to follow-up, which limits how confidently the findings could apply beyond that group even if complete results were available.
The record is informative about the intended question, follow-up design, and certain reported safety summaries. It does not establish that the treatment works or does not work. Its stated endpoint and descriptive entries should not be mistaken for a complete analysis of long-term outcomes.
13. Why This Trial Matters Statistically
This investigation is statistically notable because it addresses outcomes after the earlier CE Mark Study follow-up rather than limiting the research question to the initial study period. Long-term survival and adverse events require attention to follow-up duration, event definitions, and the handling of participants whose outcome status is not known at the end of observation. Those elements are essential for interpreting a five-year survival endpoint.
The study design also illustrates the distinction between descriptive follow-up and comparative evidence. A single-arm cohort can document outcomes in the patients observed, but without a concurrent comparator it cannot directly estimate how those outcomes differ from another strategy. This is especially important when the follow-up population consists of patients who remained ongoing and consented to continued data collection.
The record's limited statistical reporting is itself relevant. It specifies a primary endpoint and confidence-interval measure, yet gives no survival estimate or interval and reports 0 analyses. It lists secondary outcomes but does not provide their results or methods. Readers cannot assess precision, missingness, or the consistency of outcomes across measures from the record alone.
The adverse-event summary further demonstrates why denominators and event-counting rules matter. Affected-participant counts, event counts, category percentages, and rates over time answer different questions. Without a stated basis for the reported percentages or information on recurrence and exposure time, the listed safety terms remain descriptive registry summaries rather than a complete quantitative safety analysis.
These features make the record useful for understanding the intended follow-up question and for identifying what statistical information is absent. They also show why design, outcome definitions, analysis methods, and transparent reporting must be considered together when interpreting long-term clinical evidence.
14. 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 central limitation is that the registry record does not report the primary survival estimate or its 95% confidence interval. Although the endpoint and timeframe are specified, the outcome's magnitude and precision cannot be evaluated. The record also reports 0 analyses, leaving no statistical results for the primary endpoint or listed secondary measures.
The single-arm, non-randomized design has no like-for-like control group. It cannot support a comparative estimate or distinguish an observed outcome from what might have occurred under another treatment. The follow-up group is defined by continued participation after the CE Mark Study 2-year follow-up and consent to further data collection. The registry record does not report how participants who did not continue differed from those who did, which constrains generalizability.
Details needed to interpret survival are absent, including the estimator, censoring approach, analyzed population, and completeness of follow-up. The record does not report missing-data methods, outcome-specific denominators, or sensitivity analyses. For adverse events, the category definitions, timing, recurrence, exposure time, and denominator underlying the listed percentages are not stated. No conclusion about event rates or causal attribution can be drawn from the summaries alone.
The record lists 9 outcome measures but does not specify a hierarchy or multiplicity strategy. It also does not report a statistical analysis plan, adjustment methods, or interim analyses. The planning assumptions described for hypothetical sample-size illustrations do not define the actual study design or substitute for reported outcome analyses. These gaps limit assessment of both precision and the robustness of any conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: HeartMate 3 CE Mark Study Long Term Follow-up — NCT03022461.
- Registry record last updated 2022-06-27; status last verified 2022-06.
- Results first posted 2021-12-02.
- 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.
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18. Record Summary
The registry record describes a completed, prospective, multicenter, single-arm, non-blinded, non-randomized study of long-term follow-up among ongoing HM3 CE Mark Study patients who consented to continue data collection. The listed enrollment is 25, and the sponsor is Abbott Medical Devices. The primary endpoint is the percentage surviving at 5 years post HM3 CE Mark study implant, with a 95% confidence interval specified.
The record reports adverse-event entries of 25 at risk and 13 affected for serious events, 25 at risk and 0 affected for other events, and 3 deaths. It lists selected serious-event categories with percentages. However, it reports 0 analyses and does not provide the primary survival estimate, its interval, or numerical results for the listed secondary outcomes. The statistical methods, missing-data handling, analysis populations, and basis for the category percentages are not reported in the registry record.