Comparison · NCT04149535-fd8e0dfc
TAVR With Sentinel vs TAVR Without Sentinel: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
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: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First). Trial comparisons, record NCT04149535-fd8e0dfc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04149535-fd8e0dfc
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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 | 0.0227 | 0.0163 | 0.0315 | wilson | |
| Risk in group 2 | 0.0287 | 0.0214 | 0.0384 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00603 | -0.0177 | 0.00544 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.79 | 0.506 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.785 | 0.498 | 1.24 | log | |
| Number needed to treat, for one fewer participant with the outcome on TAVR With Sentinel than on TAVR Without Sentinel | 166 | 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 | 34 | 1,501 | OG000 |
| Group 2 | TAVR Without Sentinel | Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System. | 43 | 1,499 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
- Description
All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
- Time frame
- <=72 hours
- Population
- Intent-to-Treat
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.
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