Comparison · NCT04149535-deaths
TAVR With Sentinel vs TAVR Without Sentinel: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. TAVR With Sentinel vs TAVR Without Sentinel: deaths from any cause. Trial comparisons, record NCT04149535-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04149535-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00733 | 0.0041 | 0.0131 | wilson | |
| Risk in group 2 | 0.00467 | 0.00226 | 0.00961 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00266 | -0.00324 | 0.00889 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.57 | 0.61 | 4.04 | log | |
| Odds ratio, group 1 over group 2 | 1.57 | 0.608 | 4.07 | log | |
| Number needed to harm, for one more death from any cause on TAVR With Sentinel than on TAVR Without Sentinel | 376 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TAVR With Sentinel | Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.~Sentinel® Cerebral Protection System: cerebral embolic protection system | 11 | 1,501 | EG000 |
| Group 2 | TAVR Without Sentinel | Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System. | 7 | 1,499 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Events were reported to BSC from the time of enrollment through 72 hours or subject discharge (whichever comes first) for all patients. For patients with stroke within 72hrs/discharge, events were reported to BSC from the time of enrollment through 30+/-7 days post stroke. All-Cause Mortality includes all patients through 72 hours or subject discharge (whichever comes first), plus mortality through 30+/-7 days for patients that had stroke.
Source ClinicalTrials.gov
Trial
- Title
- PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
- NCT number
- NCT04149535
- Phases
- NA
- Conditions
- Stroke
- Interventions
- Sentinel® Cerebral Protection System
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2023-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04149535?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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