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 A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator (NCT05752487), a na na study. The primary outcome is Percentage of Participants With Primary Adverse Events (PAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05752487 |
| Phase | NA |
| Condition | Atrial Fibrillation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 149 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Biosense Webster, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with drug-refractory paroxysmal atrial fibrillation who were candidates for catheter ablation. The modified intention-to-treat analysis set was defined as enrolled participants who met eligibility criteria and had insertion of the study catheter; the evaluable number for the primary endpoint is not reported in the registry record.
Intervention
Catheter ablation using the THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, delivering pulsed-field or radiofrequency energy during the cardiac ablation procedure.
Comparator
There was no separate comparator group. The registry identifies a single-group study, with allocation recorded as NA, so the results do not provide a randomized or controlled comparison.
Primary question
What percentage of participants experienced a primary adverse event under the registry’s definition and timeframe? The primary endpoint is named, but its observed percentage and evaluable denominator are not reported in the registry record.
The study’s stated purpose was to evaluate the safety and effectiveness of the ablation system when used to isolate the atrial pulmonary veins in participants with paroxysmal atrial fibrillation. The registered primary outcome concerns primary adverse events rather than a direct comparison of treatment strategies. A secondary outcome concerns freedom from documented symptomatic and asymptomatic atrial arrhythmia, but its result is not reported in the registry record.
Because all participants were assigned to the same study group, the central statistical question is descriptive: what outcomes were recorded among participants treated with this system? The record does not establish how those outcomes compare with another device, another ablation approach, or no procedure. That distinction matters when interpreting both safety counts and any effectiveness claims.
3. Trial Design
This was a completed, single-group device study sponsored by Biosense Webster, Inc. It enrolled 149 participants with atrial fibrillation. The registry lists the study start as 2023-02-27 and primary completion as 2023-09-25. The phase is recorded as NA, allocation is recorded as NA, and masking is listed as NONE.
Participants with drug-refractory paroxysmal atrial fibrillation who were candidates for catheter ablation were treated using the THERMOCOOL SMARTTOUCH SF catheter and TRUPULSE generator. The system could deliver pulsed-field or radiofrequency energy during cardiac ablation procedures. The record describes one intervention group and does not identify a control arm.
The primary outcome is the percentage of participants with primary adverse events. The registry gives a timeframe of 90 days post-procedure on Day 1, while the outcome description says the percentage with primary adverse events within 7 days following the ablation procedure was reported and includes specified events occurring later than 7 days and through 90 days. The endpoint’s event list includes serious complications such as cardiac tamponade or perforation, stroke or cerebrovascular accident, and pulmonary vein stenosis, among others.
The registry also lists freedom from documented symptomatic and asymptomatic atrial arrhythmia as a secondary outcome. Three outcome measures are registered, but the other outcome details are not reported in the registry record. The registry record does not report a randomized allocation, masking, or a separate treatment group. It also does not report the rationale for the enrollment target, the protocol’s sample-size justification, or details of an interim analysis plan.
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 | Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation |
|---|---|
| STARTED | 149 |
| Study Catheter Inserted | 140 |
| COMPLETED | 137 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation |
|---|---|
| Enrolled, not treated | 9 |
| Study catheter inserted but did not undergo ablation | 1 |
| Withdrawal by Subject | 2 |
Analysis population for the primary outcome, as defined in the registry: Modified intention-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria and had insertion of the study catheter. Here, 'N' (number of participants analyzed) refers to participants who were evaluable for this outcome measure.
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: Modified intention-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria and had insertion of the study catheter.
| Characteristic | Unit | Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation |
|---|---|---|
| Participants analysed | 140 | |
| Age, Continuous | Years | 61.6 (SD 7.79) |
| Sex: Female, Male: Female | Participants | 60 |
| Sex: Female, Male: Male | Participants | 80 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Primary Adverse Events (PAEs), measured over 90 days post-procedure on Day 1.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with primary adverse events, a binary outcome: each participant is classified according to whether an event meeting the endpoint definition occurred. The registry’s event list includes atrio-esophageal fistula, pulmonary vein stenosis, device- or procedure-related death within the specified later period, permanent phrenic nerve paralysis, cardiac tamponade or perforation, stroke or cerebrovascular accident, major vascular access complication or bleeding, thromboembolism, myocardial infarction, transient ischemic attack, pericarditis, heart block, pulmonary edema or respiratory insufficiency, and vagal nerve injury or gastroparesis.
A participant-level percentage is useful for describing how often a defined safety outcome occurred in the treated group. It gives a direct summary of the frequency of participants affected, rather than a count that might include repeated events in one participant. Interpretation depends on the event definition, observation window, and number of participants evaluable for the endpoint.
The registry’s timeframe label refers to 90 days post-procedure on Day 1, while its description refers to events within 7 days and specifies certain events occurring after 7 days through 90 days. That wording should be kept in view when interpreting the endpoint. The primary percentage, its evaluable denominator, and a confidence interval are not reported in the registry record, so the endpoint’s observed frequency and precision cannot be assessed from the registry information stated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry records 149 participants at risk for serious adverse events and 23 participants affected by serious adverse events in the pulsed-field or radiofrequency catheter-ablation group. It also records 149 participants at risk for other adverse events and 90 affected by other adverse events. No deaths are listed. These are safety summaries for the one study group; they are not estimates of a difference between treatments.
The serious adverse-event terms with the highest listed percentages are atrial flutter, atrial tachycardia, cardiac tamponade, diverticulitis, and pulmonary vein stenosis, each at 1.3%; pneumonia is listed at 0.7%. These percentages describe the reported terms in this study group. The registry record does not provide event-level details such as timing, duration, severity beyond the serious classification, recurrence, or attribution for each term. The terms should not be treated as interchangeable with the specifically defined primary adverse-event endpoint: the record does not state that every term in the serious adverse-event summary qualifies as a primary adverse event.
Most importantly, the primary endpoint result itself is not reported in the registry record. The safety counts therefore cannot substitute for the primary endpoint percentage. The primary endpoint’s evaluable denominator is also not stated, and the record does not report a confidence interval for that endpoint. Without an interval or other measure of uncertainty, the precision of the primary estimate cannot be characterized.
The study’s single-group design supports description of observed outcomes among participants enrolled and treated in this study. It does not show how the outcomes would differ under another treatment or in a comparable untreated group. There is no randomized comparator from which to estimate a relative effect, and no adjustment for between-group differences is possible from the registry summary.
The secondary outcome concerning freedom from documented symptomatic and asymptomatic atrial arrhythmia is named, but its result and detailed analysis are not reported in the registry record. The record also does not report results for all three registered outcome measures. Accordingly, the available safety figures offer a limited description of adverse-event reporting, not a complete statistical account of the study’s primary safety outcome or its effectiveness outcomes.
9. Statistical Methods Explained
What kind of outcome is being summarized? The primary endpoint is a participant-level binary outcome: a participant either meets the defined primary adverse-event criterion during the stated observation period or does not. A percentage is a way to describe the frequency of participants meeting that criterion. For a binary endpoint, the denominator matters: it should be the participants who were evaluable for the outcome, which may differ from the number enrolled or at risk. The record defines the modified intention-to-treat set and says that N refers to participants evaluable for this outcome, but the evaluable number and primary percentage are not reported in the registry record.
What does a confidence interval add? General explanation: a confidence interval expresses uncertainty around an estimated quantity, such as a participant-level event percentage. It helps distinguish a relatively precise estimate from one that remains compatible with a wider range of underlying event frequencies. An interval does not correct for a poorly defined endpoint, incomplete follow-up, or bias in who was included. A confidence interval for the primary endpoint is not reported in the registry record, so its precision cannot be judged from the reported primary result.
Why does the single-group design matter? A single-group study can describe what was observed among its participants. A treatment comparison requires outcomes in groups that can be compared in a defensible way. Since the registry describes one group and no randomized comparator, it does not support a randomized treatment-effect estimate. Any observed event frequency could reflect the study intervention, participant characteristics, clinical practice, or other factors; the design as described cannot separate those explanations through a concurrent control comparison.
How should the safety summary be read? General explanation: a count of participants affected is different from a count of total events. One person may experience more than one event, so these quantities need not match. The registry’s safety summary gives participants at risk and participants affected for serious and other adverse events. It does not provide a full event-by-event account in the information. The list of serious terms and their percentages is a further description, not a substitute for the primary endpoint estimate.
What does the planning illustration represent? The stated planning assumptions describe a hypothetical two-arm calculation using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The target effect is expressed as a fraction of the observed effect. These are planning illustrations, not observed power, and they do not establish the trial’s original design rationale. The registry record does not report the trial’s own sample-size justification. In addition, the study itself is registered as a single-group study; the assumptions for a two-arm illustration should not be mistaken for evidence that the trial randomized participants between two groups.
Why can over-dispersion matter in general? General explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If it is ignored, standard errors can be understated and intervals or tests can appear more certain than warranted. It is most relevant for outcomes modeled as counts or rates when events vary more than the model allows. The primary endpoint in this study is a participant-level percentage, and the registry record does not report a model-based analysis, an over-dispersion assessment, or a statistical adjustment for it.
What can be concluded about analysis methods? The record identifies the modified intention-to-treat population definition for the primary outcome, but does not report the primary endpoint result, a confidence interval, or an inferential analysis. The number of analyses is listed as zero. Details of any covariate adjustment, model specification, handling of repeated events, or sensitivity analysis are not reported in the registry record. Those omissions limit the ability to reproduce or further assess the statistical analysis from the record alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, including the primary adverse-event percentage and a secondary outcome concerning freedom from documented symptomatic and asymptomatic atrial arrhythmia. The details and results for all outcomes are not reported in the registry record. The record does not describe a multiplicity strategy, such as a hierarchy among outcomes or an adjustment to account for multiple statistical tests. Without such information, it is not possible to determine how the study planned to control the chance of false-positive findings across several outcomes.
Missing-data handling is also not described. The record defines the modified intention-to-treat analysis set as enrolled participants who met eligibility criteria and had insertion of the study catheter. It further states that the number analyzed for the primary outcome refers to participants evaluable for that outcome. However, the number evaluable, the number with missing outcome information, reasons for missingness, and any imputation or sensitivity methods are not reported in the registry record.
These details matter because the interpretation of a percentage depends on who is included in its denominator. If participants with incomplete follow-up differ from those with complete follow-up, the observed frequency among evaluable participants may not represent the frequency in all enrolled participants. This is a general consideration, not evidence that missing outcomes occurred in this study.
The registry does not report a detailed analysis plan, outcome-specific statistical tests, or interim analyses. Their use or absence should not be inferred from the information recorded. The lack of these details, together with the absent primary endpoint result, prevents assessment of how multiplicity and missing outcome information affected the study’s reported conclusions.
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 |
|---|---|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation | 23 | 149 | 15.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation | 0 of 149 |
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 |
|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation | 90 of 149 |
Most frequent serious adverse event terms
| Event term | Organ system | Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation |
|---|---|---|
| Atrial flutter | Cardiac disorders | 2 of 149 |
| Atrial tachycardia | Cardiac disorders | 2 of 149 |
| Cardiac tamponade | Cardiac disorders | 2 of 149 |
| Diverticulitis | Infections and infestations | 2 of 149 |
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | 2 of 149 |
| Pneumonia | Infections and infestations | 1 of 149 |
| Postoperative wound infection | Infections and infestations | 1 of 149 |
| Radius fracture | Injury, poisoning and procedural complications | 1 of 149 |
| Rib fracture | Injury, poisoning and procedural complications | 1 of 149 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 149 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation |
|---|---|---|
| Atrial flutter | Cardiac disorders | 16 of 149 |
| Hypertension | Vascular disorders | 7 of 149 |
| COVID-19 | Infections and infestations | 6 of 149 |
| Atrial tachycardia | Cardiac disorders | 5 of 149 |
| Fatigue | General disorders | 5 of 149 |
| Back pain | Musculoskeletal and connective tissue disorders | 5 of 149 |
| Palpitations | Cardiac disorders | 4 of 149 |
| Headache | Nervous system disorders | 4 of 149 |
| Chest pain | General disorders | 4 of 149 |
| Puncture site haemorrhage | General disorders | 4 of 149 |
Serious events with the highest arm-level rate: atrial flutter (1.3%), atrial tachycardia (1.3%), cardiac tamponade (1.3%), diverticulitis (1.3%), pulmonary vein stenosis (1.3%).
The safety summary lists 149 participants at risk for serious adverse events and 23 participants affected. For other adverse events, it lists 149 at risk and 90 affected. It records zero deaths. These figures refer to the single pulsed-field or radiofrequency catheter-ablation group; they do not compare this group with a control group.
The serious adverse-event terms listed with percentages include atrial flutter, atrial tachycardia, cardiac tamponade, diverticulitis, and pulmonary vein stenosis at 1.3% each, and pneumonia at 0.7%. These are reported term-level figures. The registry record does not provide enough detail to infer timing, individual clinical course, or whether a listed serious event met the separate primary adverse-event definition.
Serious adverse events and primary adverse events are related safety concepts but are not automatically identical categories. The primary endpoint has its own event list and observation-period wording. Its percentage is not reported in the registry record. The safety counts therefore should be read as descriptive adverse-event information, not as the missing primary endpoint result and not as evidence of a comparative treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record describes a study of 149 participants treated with a catheter-ablation system using the THERMOCOOL SMARTTOUCH SF catheter and TRUPULSE generator. It reports participants affected by serious and other adverse events, lists several serious adverse-event terms and their percentages, and records zero deaths. These figures characterize the safety reporting for the study group as recorded.
The record does not report the observed percentage for the primary adverse-event endpoint, its evaluable denominator, or a confidence interval. It also does not report the result of the named secondary arrhythmia outcome. As a result, the available information does not establish the size or precision of the primary endpoint estimate, nor does it provide a complete account of the registered effectiveness outcomes.
Even if an outcome percentage were available, the single-group design would describe outcomes in this treated group rather than establish how outcomes compare with an alternative. There is no randomized control group in the registry record. Differences from another population or study would not by themselves establish a treatment effect because participant mix, follow-up, outcome definitions, and clinical procedures could differ.
General interpretation: an observed event frequency is a description of what was recorded during a defined period in a defined population. It is not a guarantee about what will happen to an individual, and it cannot by itself prove that an intervention caused or prevented an event. The event definitions, follow-up completeness, analysis population, and uncertainty around the estimate all matter.
The record also does not give the original sample-size rationale, detailed statistical analysis plan, missing-data methods, or multiplicity approach. Those omissions do not demonstrate that such methods were absent from study conduct; they mean that they are not reported in the registry record. The most defensible reading is therefore limited: the record supplies descriptive safety counts for one treated group, while key primary and secondary outcome results and several analysis details are unavailable.
13. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical-trial statistics: reporting safety counts is not the same as reporting the prespecified primary endpoint. The registry identifies a primary adverse-event percentage and defines the kinds of events it includes, but does not report that percentage or the evaluable denominator. Meanwhile, the safety summary contains counts of participants affected by serious and other adverse events. Readers need to keep these summaries distinct rather than treating one as a replacement for the other.
The study also illustrates how design determines the questions the data can answer. A single-group study can provide descriptive information about participants who received the intervention. Without a concurrent comparator, it cannot estimate a randomized difference between treatments. This is a limitation on causal comparison, not a statement that the study’s observed data have no descriptive value.
Endpoint definition and observation period are also central. The primary endpoint is labeled with a 90-day timeframe, while its description distinguishes events within 7 days from specified events occurring later through 90 days. Such wording needs to be understood when interpreting an endpoint frequency. Clear timing rules help readers know which events count and when participants need to be observed.
Finally, analysis-population definitions and uncertainty measures are part of the result, not technical extras. The registry describes a modified intention-to-treat set and an evaluable-outcome denominator, but does not state the evaluable number or provide the primary estimate and its precision. The absence of these details in the registry record limits independent interpretation. This case therefore highlights why a complete statistical report should connect the endpoint definition, analysis population, result, uncertainty, and design in one coherent account.
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 principal limitation for interpreting this record is that the primary endpoint is named and defined, but its observed percentage and evaluable denominator are not reported in the registry record. No confidence interval is reported for that endpoint. The available serious and other adverse-event counts cannot fill that gap because they are not necessarily the same outcome as the defined primary endpoint.
The registry identifies a single-group study with no comparator. Consequently, the recorded outcomes cannot be interpreted as a controlled estimate of the effect of the ablation system relative to another approach. The record also does not report a detailed statistical analysis plan, a sample-size justification, an interim analysis plan, missing-data methods, or a multiplicity strategy. These items are not reported in the registry record; their absence from the record does not establish what procedures were or were not used in study conduct.
The primary endpoint wording has a timing distinction: the timeframe label refers to 90 days post-procedure on Day 1, while the description refers to events within 7 days and specifies selected events occurring after 7 days through 90 days. Readers should not assume that these phrasings are identical without further clarification. The record also names a secondary arrhythmia outcome but does not report its result, and does not give details for all three registered outcome measures.
The safety summary does not supply individual event narratives, event timing, recurrence, or attribution details in the information. It is therefore a limited descriptive account. The enrolled total of 149 should not automatically be treated as the evaluable denominator for the primary endpoint, since that denominator is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator — NCT05752487.
- Registry record last updated 2025-07-01; status last verified 2025-06.
- Results first posted 2024-10-16.
- 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
NCT05752487 is a completed, single-group study sponsored by Biosense Webster, Inc., evaluating the THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator for paroxysmal atrial fibrillation. The registry lists enrollment of 149 participants, a start date of 2023-02-27, and primary completion on 2023-09-25. Masking is listed as NONE and allocation as NA.
The primary outcome is the percentage of participants with primary adverse events. The registry reports safety counts of 23 participants affected by serious adverse events and 90 affected by other adverse events, with 149 at risk in each category and zero deaths. The primary endpoint percentage, its evaluable denominator, and the result for the named secondary arrhythmia outcome are not reported in the registry record. Because this is a single-group study, the reported safety information is descriptive rather than a randomized treatment comparison.