Comparison · NCT03795298-990d441a
Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: ISTH Major Bleeding
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. Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: ISTH Major Bleeding. Trial comparisons, record NCT03795298-990d441a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03795298-990d441a
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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 | 0.0477 | 0.0349 | 0.0648 | wilson | |
| Risk in group 2 | 0.0374 | 0.0263 | 0.0528 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0103 | -0.00973 | 0.0307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.799 | 2.04 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.791 | 2.1 | log | |
| Number needed to treat, for one more participant with the outcome on Oral Anticoagulant (Control) than on WATCHMAN FLX DEVICE | 96.9 | 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 | Oral Anticoagulant (Control) | Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial | 38 | 797 | OG000 |
| Group 2 | WATCHMAN FLX DEVICE | Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit | 30 | 803 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- ISTH Major Bleeding
- Description
- Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee
- Time frame
- From randomization to 1095 days post randomization
- Population
The primary analysis for the secondary endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
- NCT number
- NCT03795298
- Phases
- NA
- Conditions
- Atrial Fibrillation
- Interventions
- WATCHMAN FLX Implant, Market-approved OAC
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2025-09-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03795298?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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