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 Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH) (NCT04512703), a registered phase not stated study. The primary outcome is Logistics of Study Device Setup and Monitoring.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04512703 |
| Phase | Phase not stated |
| Condition | Heart Arrhythmia |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Zoll Medical Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 51 participants in a healthy group and an arrhythmia monitoring group. The overview describes healthy adult volunteers aged 21 years or older and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring. The group descriptions specify participants older than 21 years. The registry record does not give further eligibility details or report how participants were recruited.
Intervention
Participants wore the µCor Heart Failure and Arrhythmia Management System, a device intended to capture thoracic fluid content, electrocardiogram, heart rate, respiratory rate, activity, and body posture without invasive procedures. The healthy group was to wear the device for up to 30 days; the arrhythmia monitoring group was to wear it for up to 90 days. The study assessed whether devices could be set up and transmit data to a remote server.
Comparator
This was a prospective, non-interventional feasibility study, not a randomized treatment comparison. The registry describes front-position and side-position devices, with 51 of each, and separate healthy and arrhythmia monitoring groups. It does not describe allocation to positions or establish that the groups were intended as like-for-like controls. Comparisons between these groups therefore should not be read as causal treatment contrasts.
Primary question
The primary endpoint asked how many participants were successfully fitted with a device able to transmit data to the remote server. Setup was assessed at the start of device wear, and monitoring was assessed across the stated study periods. This is a practical feasibility question about deployment and data transmission, rather than a question about whether the device improves a clinical outcome. The registry record does not report the observed endpoint counts, so the degree of setup or monitoring success cannot be determined from the posted results.
3. Trial Design
The registry describes PATCH as a prospective, non-interventional feasibility study of the µCor Heart Failure and Arrhythmia Management System. It was marked completed, with enrollment of 51. The record gives a study start date of 2018-10-25 and a primary completion date of 2020-08-02. It describes the study duration as 8 months from screening start to study completion, and a multicenter study with a maximum of 8 centers in Europe. The record does not state how many centers actually enrolled participants.
Two participant groups are described. The Healthy Group included healthy male and female volunteers; participants were to wear the device for up to 30 days. The Arrhythmia Monitoring Group included patients with a clinical indication for outpatient cardiac monitoring; participants were to wear the device for up to 90 days. The study overview describes adult volunteers and patients, while the group descriptions specify participants older than 21 years. The registry does not give further details about eligibility assessment, recruitment, or the numbers enrolled in each group beyond the safety denominators.
The device descriptions also distinguish front and side positions. The primary outcome description states that there were 51 side-position devices and 51 front-position devices. It does not explain how these placements were assigned, whether the same participants used both positions, or whether position comparisons were paired. Allocation is not stated, and the record explicitly does not present the arms as a like-for-like control comparison.
The record lists 12 outcome measures, including thoracic fluid content, respiration rate, activity, and sleep-angle comparisons between front and side device measurements, along with association of device recordings to clinical events and recording stability. It reports 0 analyses. No protocol-level statistical plan, sample-size justification, interim analysis plan, or detailed analysis population is 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.
Before assignment: An additional subject was enrolled beyond the protocol in the arrhythmia group.
Within 7 Days From Start of Device Wear
| Stage | Healthy Group | Arrhythmia Monitoring Group |
|---|---|---|
| STARTED | 6 | 45 |
| Wore Front Position | 6 | 45 |
| Wore Side Position | 6 | 45 |
| COMPLETED | 6 | 45 |
| NOT COMPLETED | 0 | 0 |
Between 7th and 90th Day of Device Wear
| Stage | Healthy Group | Arrhythmia Monitoring Group |
|---|---|---|
| STARTED | 6 | 45 |
| Wore Side Position Device | 3 | 23 |
| Wore Front Position Device | 3 | 22 |
| COMPLETED | 6 | 45 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All devices in both Healthy and Arrythmia Monitoring Group were assessed for setup at the beginning of Period 1. Monitoring assessment was assessed during both Period 1 and Period 2. There was a total of 51 side position devices and 51 front position devices.
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 | Healthy Group | Arrhythmia Monitoring Group | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 45 | 51 | |
| Age, Continuous | years | 35 (25 to 56) | 61 (19 to 79) | 58 (19 to 79) |
| Sex: Female, Male: Female | Participants | 3 | 23 | 26 |
| Sex: Female, Male: Male | Participants | 3 | 22 | 25 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Germany | participants | 6 | 45 | 51 |
6. Primary Endpoint
The registry lists the primary outcome as Logistics of Study Device Setup and Monitoring, measured over Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | count of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Logistics of Study Device Setup and Monitoring and is measured as a count of participants. It concerns whether a participant was successfully fitted with a device that could transmit data to the remote server. The registry distinguishes setup from subsequent monitoring: setup was assessed at the beginning of Period 1, while monitoring was assessed during Period 1 and Period 2. Period 1 runs from the start of device wear at Day 0 to Day 7; Period 2 is Day 8 to 90.
This endpoint is used because successful fitting and reliable transmission are practical prerequisites for collecting remote monitoring data. In a feasibility study, counts of successful setup and monitoring can describe whether the system can be deployed and whether it can communicate with the server during the specified observation periods. Such measures address operational performance, not clinical benefit or diagnostic accuracy.
The registry record gives the endpoint definition and states that all devices in both groups were assessed for setup. It does not report the observed counts of participants successfully fitted or able to transmit data, nor does it provide period-specific outcome values. Although the record states that 51 front-position devices and 51 side-position devices were assessed, those device counts do not, by themselves, give the number of participants meeting the primary endpoint. The actual endpoint result and its precision are therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record defines a primary feasibility endpoint but does not report its observed results. It does not provide the number of participants successfully fitted with a transmitting device, the number with successful monitoring, or any estimates of uncertainty for these outcomes. Consequently, the posted information cannot establish the observed level of setup or monitoring success. This is an absence of reported endpoint results, not evidence that setup or transmission failed.
The enrollment was 51, and the record describes healthy volunteers and patients with an indication for outpatient cardiac monitoring. These groups have different descriptions and wear periods, so they should not automatically be treated as exchangeable comparison groups. The record also does not state allocation to the front or side device positions or whether participants contributed measurements in both positions. Any apparent differences by group or position would require the underlying outcome data and design details to interpret.
The title and listed outcome measures indicate an interest in feasibility and device recordings. The record also lists secondary measures concerning equivalency of front and side measurements, association with clinical events, and recording stability. But it gives no reported results for those measures and lists 0 analyses. It is therefore not possible to assess measurement agreement, clinical-event associations, stability, or statistical evidence for any comparison from the registry record.
General statistical interpretation: a count is informative only alongside a clear definition of the denominator and the observation period. For a feasibility endpoint, a proportion and an uncertainty interval can help show how precisely the observed success rate is estimated. Those quantities are not reported, and they cannot be reconstructed from the enrollment total or device counts alone. The number of devices in each position does not tell how many met the endpoint.
The posted planning assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. Such planning illustrations are not observed trial results and are not observed power. The registry record does not give the trial’s own sample-size justification, and the absence of primary outcome results means the magnitude of any observed effect cannot be assessed from the posted record. Any interpretation should therefore remain descriptive and limited to the design and endpoint definitions that are reported.
9. Statistical Methods Explained
The methods information in the registry record is limited. It identifies a prospective, non-interventional feasibility design, defines a count-based primary endpoint, describes two participant groups and two device positions, and lists secondary outcomes. It does not report the primary outcome counts or analyses. The statistical concepts below explain how such information is generally interpreted; they do not fill in unreported study results.
What does a count endpoint represent?
The primary measure is a count of participants who were successfully fitted with a device able to transmit data to a remote server. Counts are often useful for operational outcomes because they state how many people met a specified criterion. To interpret a count, readers also need its denominator, the exact success definition, and the time period over which success was assessed. The registry describes setup at the beginning of Period 1 and monitoring across Period 1 and Period 2, but does not report the corresponding observed counts.
General statistical explanation: counts can be presented as event counts, and, when the eligible denominator is known, as proportions. An uncertainty interval around a proportion expresses the range of values compatible with the observed data under the chosen statistical method. Wider intervals indicate less precision; narrower intervals indicate greater precision. Neither a count nor an interval establishes that a device is clinically beneficial. For PATCH, the registry record does not provide the outcome counts needed to report such an estimate or interval.
Why does the design matter for comparisons?
The record labels the study non-interventional and does not state allocation. It describes a Healthy Group and an Arrhythmia Monitoring Group, along with front-position and side-position devices. These descriptions do not establish random assignment or a controlled contrast. Participants in the two groups differ by the reason for monitoring, and their intended wear periods differ. A difference in outcomes between these groups, if one were reported, could reflect differences in participants, follow-up, or other factors rather than a device effect.
General statistical explanation: random allocation can help balance measured and unmeasured characteristics between treatment groups, while observational comparisons may remain affected by confounding. A paired comparison of device positions would also require information that the same participants or measurement occasions contributed to both positions. The registry record does not state whether position measurements were paired, so the appropriate statistical model for a position comparison cannot be established from the available description.
What does measurement equivalency require?
Several listed secondary outcomes concern equivalency of front and side measurements for thoracic fluid content, respiration rate, activity, and sleep angle. The word equivalency describes a question about whether measurements are sufficiently alike according to a prespecified margin. General statistical explanation: a formal equivalence analysis needs a defined margin and an analysis that estimates the measurement difference with appropriate uncertainty. A failure to detect a difference is not, by itself, proof of equivalence. The registry record does not report equivalence margins, analysis methods, or results.
The record also lists association of device recordings to clinical events and device recording stability. These are distinct questions. Association concerns how recorded measurements relate to clinical events; stability concerns consistency of recordings over time or across conditions, depending on the prespecified definition. General statistical explanation: each question needs a defined outcome, time window, and analysis method. These details and the corresponding results are not reported in the registry record.
How should planning illustrations be read?
The planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect expressed as a stated fraction of an observed effect. General statistical explanation: sample-size planning uses assumptions about the effect to be detected, outcome variability, significance threshold, and desired power. Changing the assumed effect changes the sample size required. A planning calculation is conditional on its assumptions and does not show what the trial observed.
The stated illustrations are not the trial’s own design justification, and sample-size illustrations must not be read as observed power. The registry record does not report the trial’s sample-size rationale or observed primary endpoint effect. No numerical planning values or effect estimates are reported in the registry record, so the assumptions alone do not support a conclusion about whether enrollment was adequate for a particular statistical objective.
What is the role of uncertainty and analysis reporting?
General statistical explanation: point estimates describe the observed data, while confidence intervals communicate uncertainty around those estimates under a statistical model. A p-value, when appropriate, describes how compatible the data are with a specified null hypothesis under the assumptions of the test; it is not the probability that a hypothesis is true and does not measure clinical importance. A feasibility study may prioritize descriptive estimates over hypothesis tests, but the specific plan should be stated rather than assumed.
The registry lists 0 analyses and provides no estimates, confidence intervals, or p-values for the primary endpoint. Therefore, no inferential conclusion can be drawn about the endpoint from the posted record. General statistical explanation: when data are clustered by study center or repeated within participants, an analysis may need to account for that dependence. The study is described as multicenter, but the number of active centers, clustering structure, and analysis adjustments are not reported. These details should not be inferred.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the primary logistics endpoint and secondary device-measurement, clinical-event, and recording-stability outcomes. It does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for testing multiple hypotheses. It also lists 0 analyses, so no outcome-specific estimates or tests are reported in the registry record.
General statistical explanation: when many outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase if each is assessed separately. Prespecifying a primary outcome and a testing strategy can help clarify which findings are confirmatory and which are exploratory. The outcome list identifies a primary endpoint, but does not supply enough information to determine how secondary outcomes were prioritized or interpreted statistically. No multiplicity adjustment should be presumed.
Missing-data methods are not reported in the registry record. The posted information does not state whether any participants withdrew, whether device transmission was interrupted, how incomplete monitoring periods were handled, or whether missing measurements were excluded or imputed. These matters are particularly relevant to feasibility outcomes because unavailable transmission data may affect whether monitoring success can be assessed. Without participant-level completeness information and a prespecified handling rule, the direction and possible impact of missingness cannot be evaluated.
The analysis populations are also not reported in the registry record. The endpoint description refers to all devices in both groups for setup assessment and monitoring assessment across the stated periods, but it does not define an analysis set or explain how participants with partial device use were treated. The enrollment total and device-position totals do not establish the denominator used for any endpoint analysis. These omissions limit assessment of both the representativeness of the reported results and the precision of any estimate; in this record, the endpoint results themselves are not reported.
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 |
|---|---|---|---|
| Healthy Group | 0 | 6 | 0.0% |
| Arrhythmia Monitoring Group | 0 | 45 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Healthy Group | 0 of 6 |
| Arrhythmia Monitoring Group | 0 of 45 |
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 |
|---|---|
| Healthy Group | 6 of 6 |
| Arrhythmia Monitoring Group | 42 of 45 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Healthy Group | Arrhythmia Monitoring Group |
|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | 6 of 6 | 42 of 45 |
The registry lists serious adverse event counts separately for the Healthy Group and the Arrhythmia Monitoring Group. Serious adverse events were reported for 0 of 6 participants in the Healthy Group and 0 of 45 participants in the Arrhythmia Monitoring Group. Deaths were reported as 0 in each group. These are the counts recorded in the safety summary, not estimates of comparative risk.
The registry also gives counts for other adverse events: 6 of 6 participants in the Healthy Group and 42 of 45 participants in the Arrhythmia Monitoring Group were recorded as affected. The record does not provide event terms for serious events, and the list of top serious terms is empty. It does not supply the nature, severity, timing, duration, or attribution of the other adverse events in the information. The categories should not be conflated: the figures for other adverse events are not the serious adverse event figures.
General statistical explanation: adverse event counts are descriptive. They depend on how events were defined, collected, and attributed, as well as the number of participants observed and duration of observation. The intended wear periods differed between groups, and the record does not give person-time or detailed follow-up completeness. The group figures therefore should not be compared as if they arose from randomized, equally observed arms. These registry counts alone do not establish that the device caused or prevented an event.
12. What the Result Does, and Does Not, Mean
The record describes a prospective feasibility study focused on remote device setup, data transmission, and several measurement-related outcomes. It gives an operational definition for the primary endpoint and identifies periods for setup and monitoring. This tells readers what the study intended to assess, but not how many participants achieved the endpoint. The observed primary results are not reported in the registry record.
The enrollment of 51 and the reported safety denominators describe the scale and group structure of the study, but do not substitute for the missing endpoint counts. Likewise, the record’s 51 front-position devices and 51 side-position devices describe device placement totals, not the success of setup or monitoring. Without outcome values and denominators for each measure, neither the frequency nor the precision of feasibility outcomes can be judged.
The study’s non-interventional design and unstated allocation also constrain comparisons. The healthy and arrhythmia monitoring groups represent different participant descriptions and intended wear durations. The record does not establish a randomized control group or specify the relation between participants and the two device positions. Any observed group or position contrast would need to be interpreted in light of those design details; the registry record does not report the results or enough methods to make that assessment.
General statistical explanation: feasibility findings address whether procedures and data collection can be carried out under study conditions. They are not equivalent to evidence of clinical effectiveness, measurement validity, or improved health outcomes. Likewise, a sample-size planning illustration cannot be treated as observed power or as a result. The posted record does not report statistical analyses, outcome estimates, or uncertainty intervals.
Accordingly, the information supports a description of the study’s aims, population categories, device use, endpoint definition, and reported safety counts. It does not support a quantitative conclusion about successful monitoring, front-versus-side equivalency, association with clinical events, recording stability, or a treatment effect. Those conclusions would require outcome data and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because its main question is operational rather than a conventional comparison of clinical treatments. For remote monitoring, successful fitting and transmission are prerequisites for obtaining usable recordings. A count-based endpoint can make that practical question explicit, provided the success criterion, denominator, observation period, and handling of incomplete data are clear.
The registry gives useful structural details: 51 participants were enrolled; the study included a healthy group and an arrhythmia monitoring group; intended wear periods differed; and device positions were described as front and side. It also identifies secondary questions about measurement equivalency, association with clinical events, and recording stability. These details help distinguish the study’s feasibility focus from claims about clinical benefit.
The same record illustrates why outcome reporting matters. A clearly defined endpoint is not enough to assess feasibility without the observed number meeting that endpoint and the denominator used. Uncertainty estimates would help indicate how precisely the result represents the study participants. For position comparisons, details about assignment and whether measurements were paired would guide the analysis. For a multicenter study, information about center contributions can also matter if outcomes are correlated within centers.
General statistical explanation: feasibility studies often generate estimates that inform later study planning, but those estimates remain uncertain and depend on the recruited population and study procedures. A planning illustration based on an assumed fraction of an observed effect is conditional on that effect and the other stated assumptions; it does not establish that the original study was designed to test a clinical hypothesis. The registry record does not state its original sample-size rationale.
The statistical value of this record is therefore chiefly in its documented questions and design context. The absence of posted endpoint analyses means readers cannot evaluate whether the operational goals were met or how precisely outcomes were measured. Transparent reporting of counts, denominators, missingness, and analysis methods would be necessary to answer those questions.
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 most direct limitation is that the primary endpoint is defined but its observed results are not reported in the registry record. No successful setup or monitoring counts, estimates, or uncertainty intervals are given. The record lists 0 analyses, so the posted information does not permit a statistical assessment of the primary or secondary outcomes.
The allocation method is not stated. The record explicitly cautions that the groups are not a like-for-like control comparison, and the study is described as non-interventional. The healthy and arrhythmia monitoring groups differ in their participant descriptions and intended device wear periods. The position descriptions do not establish how front or side placement was assigned, whether participants used both positions, or how measurements were linked across positions.
Further reporting limitations include the absence of a stated sample-size justification, protocol-level statistical plan, interim-analysis information, analysis populations, and methods for missing data. The registry lists 12 outcome measures but does not report how multiplicity was addressed. It also does not provide actual center participation or details of center-level analysis. These omissions make it difficult to assess precision, completeness, or the basis for any comparison.
The safety summary gives serious and other adverse event counts, but lacks detail about event terms, timing, severity, attribution, and follow-up completeness. The record’s empty list of top serious event terms does not provide clinical characterization. In addition, the safety denominators do not establish the denominators used for the primary endpoint.
These limitations concern what the registry record reports; they do not establish that the unreported data were not collected. Without posted outcomes and methods, conclusions about feasibility, measurement equivalency, clinical-event association, or recording stability remain unresolved.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH) — NCT04512703.
- Registry record last updated 2021-06-03; status last verified 2021-06.
- Results first posted 2021-06-03.
- 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
PATCH is a completed, prospective, non-interventional feasibility study of the µCor Heart Failure and Arrhythmia Management System. The registry reports enrollment of 51, a start date of 2018-10-25, and a primary completion date of 2020-08-02. The study involved healthy volunteers and patients with a clinical indication for outpatient cardiac monitoring, with intended wear periods of up to 30 days and up to 90 days, respectively.
The primary endpoint counted participants successfully fitted with a device able to transmit data to a remote server. Setup and monitoring were assessed across the stated periods, and the study also listed secondary measures involving device recordings and front-versus-side measurements. The registry reports 51 front-position devices and 51 side-position devices, and lists 12 outcome measures and 0 analyses.
The safety summary reports 0 serious adverse events and 0 deaths in each group, with other adverse events recorded for 6 of 6 healthy participants and 42 of 45 participants in the arrhythmia monitoring group. The registry record does not report primary endpoint results, secondary outcome analyses, missing-data methods, or a detailed statistical plan.