SIMPLAAFY Clinical Trial
← catalyst calendarSponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Prevention
Enrollment
1,857actual
Sites
86
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-01 | actual | When the study began enrolling |
| Primary completion | 2026-07-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-07-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Atrial Fibrillation
- Stroke
- Bleeding
Intervention
- Device: WATCHMAN FLX Pro LAAC Device — also filed as WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Primary outcomes
what the primary-completion date above is the date OFReduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm
measured 6 months after randomization
Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm.
measured 6 months after randomization
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