SIMPLAAFY Clinical Trial
Why SIMPLAAFY Clinical Trial?
The current post-implant antithrombotic therapy options include short-term OAC with a full-dose NOAC and aspirin for the first 45 days post-implant followed by P2Y12 and aspirin until 6 months post-implant or DAPT only including P2Y12 and aspirin for 6 months post implant. Patients remain on aspirin indefinitely. These current options may still carry bleeding risk during the peri-procedural period.
SIMPLAAFY is a randomized controlled trial that will evaluate two monotherapy regimens vs. DAPT after implant with the WATCHMAN FLX™ Pro Device in patients with AF. SIMPLAAFY will assess whether a less intensive drug regimen may help mitigate post-implant bleeding risk and provide other viable options for post-implant treatment.
Trial Design and Primary Endpoints
Primary Endpoints:
- Reduced dose NOAC Primary Endpoint: Composite rate of all death, all stroke, systemic embolism and major bleeding at 6-months after randomization
- Aspirin Primary Endpoint: Composite rate of all death, all stroke, systemic embolism and major bleeding at 6-months after randomization
Trial Timeline
Patient Brochure
View the orderable patient-facing brochure created to give your trial candidates an overview of the SIMPLAAFY clinical trial.
Contact your WATCHMAN Representative to order patient brochures for your center.
Patient Selection
Find a Trial Site
Boston Scientific has selected US sites to be SIMPLAAFY investigational centers. If you have a candidate in mind, view the active trial list provided by clinicaltrials.gov, and reach out to a study physician near you to discuss next steps for referral.