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Comparison · NCT03795298-deaths

Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: 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

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ConductScience Library. Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: deaths from any cause. Trial comparisons, record NCT03795298-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03795298-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.04390.03170.0605wilson
Risk in group 20.03860.02730.0543wilson
Risk difference, group 1 minus group 20.00531-0.01450.0253newcombe hybrid score
Risk ratio, group 1 over group 21.140.7091.83log
Odds ratio, group 1 over group 21.140.6981.87log
Number needed to harm, for one more death from any cause on Oral Anticoagulant (Control) than on WATCHMAN FLX DEVICE188from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Oral Anticoagulant (Control)Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial35797EG000
Group 2WATCHMAN FLX DEVICECatheter 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 visit31803EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization

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

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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