INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study (NCT04346537), a registered phase not stated study. The primary outcome is Primary Safety: Lead-related Complication-Free Rate.

2. Clinical Question

The study concerns the INGEVITY+ Active Fixation Pace/Sense Lead in participants with bradycardia. Its stated objective was to confirm the safety and effectiveness of the lead. The primary question was whether the lead-related complication-free rate met the stated performance goal of 93%. The primary endpoint was defined as a percentage of leads, with a 97.5% confidence interval and a Kaplan-Meier calculation described in the registry record.

3. Trial Design

The registry record identifies this as a clinical study of a device: the INGEVITY+™ Pace/Sense Lead. The stated objective was to confirm the lead’s safety and effectiveness. The condition listed is bradycardia, and enrollment is reported as 109. The record marks the study as completed, with a start date of 2020-08-06 and a primary completion date of 2021-03-01.

This is not a randomized comparison. The allocation description does not state how participants were assigned, and a control group or comparator is not reported in the registry record. The posted adverse-event group is named “INGEVITY+ Study Participants.” these registry entries do not establish details about treatment allocation beyond what the record explicitly states.

The primary outcome was lead-related complication-free rate. The record also lists secondary efficacy outcomes for sensed amplitude in right atrial leads, sensed amplitude in right ventricular leads, and pacing impedance. It reports five outcome measures and three analyses, but does not provide the analysis details needed to map each listed measure to a particular method or result.

The primary endpoint description contains two different follow-up windows: its timeframe field says “Lead Implant through 3-Months Post-Implant,” while its description says the endpoint evaluated complications from three months post-implant through twelve months post implant. The registry record does not explain this difference. It also does not report a detailed protocol, eligibility criteria, or a sample-size justification.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

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

Population: Baseline characteristics are reported on enrolled participants.

6. Primary Endpoint

The registry lists the primary outcome as Primary Safety: Lead-related Complication-Free Rate, measured over Lead Implant through 3-Months Post-Implant.

The primary endpoint is the lead-related complication-free rate, expressed as a percentage of leads. The endpoint description says the rate was calculated using Kaplan-Meier methodology and gives a performance goal of 93%. The confidence interval is identified as 97.5%, but the interval limits and the observed rate are not reported in the registry record.

General statistical context: a complication-free rate describes the proportion estimated to remain free of the event of interest over a specified follow-up period. A time-to-event method such as Kaplan-Meier can account for differing follow-up times and for participants whose event status is not observed through the full follow-up period, subject to the method’s assumptions. The registry record does not state how follow-up, censoring, or event adjudication was handled in this study.

A performance goal provides a reference value against which the endpoint may be evaluated. The record reports the goal as 93%, but does not report the observed estimate or the confidence limits needed to assess its precision relative to that goal. The timeframe discrepancy in the endpoint description also leaves the intended interval for interpreting the rate unclear.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a time-to-event measure: lead-related complication-free rate. The record says Kaplan-Meier methodology was used and identifies a 97.5% confidence interval. It does not report the estimate, interval limits, event count for this endpoint, or details of the analysis population. Accordingly, the named method can be explained, but the study-specific estimate and its precision cannot be interpreted from the registry record.

What does a Kaplan-Meier estimate represent?

General statistical context: Kaplan-Meier estimation describes the probability of remaining free of an event over time. It uses the observed times to events and the time contributed by participants who have not yet had an event. A participant whose observation ends before an event is observed may be censored, meaning that the participant contributes information up to the last known event-free time. Censoring does not mean that an event did or did not occur afterward; it means that later event status is not available to the analysis.

The usefulness of this method depends on the study’s follow-up information and assumptions about censoring. The registry record does not state the censoring rules, how missing or incomplete follow-up was handled, whether events were adjudicated, or whether the calculation was performed at the lead or participant level beyond describing the endpoint unit as a percentage of leads. Those details matter when interpreting a time-based estimate.

How should the confidence interval be read?

General statistical context: a confidence interval communicates the uncertainty around an estimated quantity under the analysis method. A narrower interval indicates greater precision than a wider interval, while the interval’s position relative to a reference value can inform an inferential comparison. Here, the record identifies a 97.5% confidence interval and a performance goal of 93%, but it does not give the interval limits or the endpoint estimate. The interval’s width and its relation to the goal therefore cannot be assessed.

What does a performance goal contribute?

A performance goal is a benchmark specified for interpreting an endpoint. The record names 93% as the goal for the complication-free rate. A benchmark is not itself an observed result, and its presence does not show whether the study estimate met it. That assessment requires the actual estimate and the relevant inferential results. Neither is reported in the registry record.

The endpoint description has a timing inconsistency: one field says implant through 3-Months Post-Implant, whereas the description says the endpoint evaluates complications from three months post-implant through twelve months post implant. The record does not reconcile these periods. The difference is material to interpretation because a rate is tied to its follow-up interval; the stated estimate cannot be understood fully without knowing which interval was analyzed.

What can be said about planning illustrations?

General statistical context: sample-size calculations illustrate how many observations might be needed under specified assumptions to detect a defined effect with a chosen error rate and power. They are planning tools, not evidence that a study achieved that power or observed a particular effect. The record describes illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. It also distinguishes total events for time-to-event illustrations from participants per arm for other illustrations.

The study is not a randomized comparison, and the record does not identify a comparator or an allocation procedure. The planning assumptions therefore should not be mistaken for a description of the actual study design. Numerical illustration results and the trial’s own sample-size justification are not reported in the registry record. The record also does not report an observed-power calculation; in any case, planning illustrations should not be presented as observed power.

What cannot be inferred from the listed analyses?

The registry record reports five outcome measures and three analyses, but does not describe the methods for each analysis. It does not report whether estimates were adjusted, which statistical tests were used for secondary outcomes, or how uncertainty was quantified for those outcomes. The names of the secondary measures do not substitute for their estimates, analysis populations, or precision measures. No further statistical conclusions can be drawn from the analysis count alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary safety endpoint and secondary efficacy measures for right atrial sensed amplitude, right ventricular sensed amplitude, and pacing impedance. It reports five outcome measures and three analyses. It does not report how the analyses correspond to the outcomes, whether a prespecified testing hierarchy was used, or whether any adjustment for multiple comparisons was planned or performed.

Multiplicity matters when several outcomes or statistical tests are considered because the chance of at least one apparently unusual result can change as the number and relationship of tests change. General statistical context: analysts may address this through a prespecified hierarchy, adjustment procedures, or a clear distinction between confirmatory and exploratory results. The registry record does not report which, if any, approach was used. Since the outcome-specific estimates and inferential results are also not reported, the implications of multiplicity cannot be evaluated.

Missing-data methods and analysis populations are not described in the registry record. It does not state how incomplete follow-up, missing outcome measurements, or withdrawals were handled, nor does it identify a population definition for the primary or secondary analyses. The adverse-event figures use 101 participants at risk, while total enrollment is reported as 109; the record does not explain the difference or establish that the populations for these entries match the endpoint analysis population.

The primary endpoint’s timeframe is described in two different ways, and the record does not clarify which interval governed analysis. These omissions limit assessment of the endpoint definition, analysis choices, and robustness of the findings.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: dislodgment - related to right atrial lead (1.0%), myocardial perforation post-implant - related right atrial lead (1.0%), hemothorax (1.0%), post-surgical infection (<=30 days post-implant) (1.0%), atrial fibrillation (1.0%).

The registry record reports adverse-event figures for “INGEVITY+ Study Participants.” It lists 101 at risk for the serious-event entry, with 8 affected; for other adverse events, it lists 101 at risk, with 10 affected. It also reports 1 death. The record does not provide further detail about the definitions used for these categories, the observation period for each count, or whether participants could appear in more than one category.

The serious-event terms listed are “Dislodgment - related to right atrial lead,” “Myocardial perforation post-implant - related right atrial lead,” “Hemothorax,” “Post-surgical infection (<=30 days post-implant),” “Atrial fibrillation,” and “Chest pain.” Each is reported as 1.0%. These terms and percentages should be read as registry entries, not as a complete clinical account of event timing, severity, or attribution. The record does not report the denominator or analysis details for each term separately.

The adverse-event figures do not replace the primary endpoint result. The relationship between these events and the lead-related complication-free analysis, including event adjudication and overlap, is not reported in the registry record.

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

The registry record establishes that a completed clinical study evaluated the INGEVITY+ Active Fixation Pace/Sense Lead, with a stated objective of assessing safety and effectiveness. It identifies bradycardia as the condition, reports enrollment of 109, names a lead-related complication-free rate as the primary safety endpoint, and states a performance goal of 93%. It also specifies Kaplan-Meier methodology and a 97.5% confidence interval.

Those design and endpoint details do not reveal the observed primary result. The registry record does not report the complication-free rate, confidence limits, or an inferential comparison with the performance goal. It therefore does not show whether the observed estimate was above, below, or compatible with the goal, nor how precise an estimate would be. The conflicting descriptions of the endpoint timeframe further limit interpretation.

The record also names secondary efficacy outcomes but does not report their results. Adverse-event figures are available, including 8 participants with serious adverse events among 101 at risk, 10 with other adverse events among 101 at risk, and 1 death. These figures should not be treated as estimates of the primary endpoint, or as a substitute for a complete account of event attribution and follow-up.

The study is not described as a randomized comparison, and no comparator is reported. Its registry entry therefore does not establish a comparative treatment effect. The available information also does not document the analysis population, missing-data handling, multiplicity approach, or the trial’s sample-size justification. Statistical interpretation should remain limited to the study features and adverse-event entries the record actually reports.

13. Why This Trial Matters Statistically

This study illustrates why a named endpoint and statistical method are not enough to interpret a clinical result. The registry record specifies a complication-free rate, a performance goal, a confidence-interval level, and Kaplan-Meier methodology. But without the observed estimate and interval limits, readers cannot assess the endpoint’s magnitude or precision, or its relationship to the goal.

It also highlights the importance of an unambiguous estimand and follow-up period. The endpoint timeframe field and endpoint description give different intervals. Since event-free rates depend on the time period being assessed, that discrepancy must be resolved before the endpoint can be understood fully. Clear reporting of the analysis population, event definition, follow-up, and censoring would support a more complete evaluation.

The record reports adverse-event counts and a set of event terms, while leaving the primary endpoint result and secondary efficacy results unreported. This distinction matters: safety listings, endpoint estimates, and comparative evidence answer different statistical questions. A record that identifies outcomes without reporting their estimates does not allow readers to infer those results.

Finally, the entry demonstrates the limits of interpreting planning assumptions as study findings. The record describes sample-size illustrations, but those are planning scenarios and are not observed power. It does not report the study’s own sample-size justification. Keeping design assumptions, observed outcomes, and the precision of estimates distinct is essential when assessing what a registry entry can establish.

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 primary endpoint result is not reported in the registry record. Although the record specifies a 93% performance goal, a 97.5% confidence interval, and Kaplan-Meier methodology, it gives neither the estimated complication-free rate nor the confidence limits. The endpoint’s follow-up period is also inconsistent across its description and timeframe field: one refers to implant through 3-Months Post-Implant and the other to three months post-implant through twelve months post implant. No clarification is reported.

The record does not report endpoint event counts, the number of leads in the primary analysis, event adjudication procedures, censoring rules, or handling of incomplete follow-up. It also does not report the analysis populations or missing-data methods. Although enrollment is 109 and the adverse-event entries list 101 at risk, the reason for this difference is not reported in the registry record.

The record does not provide results for the named secondary efficacy measures, or specify how the listed analyses map to outcomes. It does not report a multiplicity strategy, the study’s sample-size justification, or detailed eligibility criteria. A comparator is not reported, and the study is not a randomized comparison; allocation is not stated. These limitations prevent a comparative-effect estimate and restrict interpretation to the study details and adverse-event entries that are reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study — NCT04346537.
• Registry record last updated 2022-07-14; status last verified 2022-07.
• Results first posted 2022-05-12.
• 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.

18. Record Summary

The completed INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study lists bradycardia as its condition and reports enrollment of 109. The study start date is 2020-08-06, and the primary completion date is 2021-03-01. The stated objective was to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

The primary safety endpoint was lead-related complication-free rate, with a stated performance goal of 93%, a 97.5% confidence interval, and Kaplan-Meier methodology. The observed rate and confidence limits are not reported in the registry record, and the endpoint timeframe is described inconsistently. Secondary measures concern sensed amplitude in right atrial and right ventricular leads and pacing impedance; their results are not reported. Adverse-event entries list 8 serious-event participants and 10 participants with other adverse events among 101 at risk, and 1 death. A comparator, detailed analysis populations, missing-data methods, and multiplicity methods are not reported in the registry record.