SIMPLAAFY Patient Selection
Who is a SIMPLAAFY Patient?
Qualified trial patients must meet all the following criteria.
✓ Patient is at increased risk for stroke systemic embolism based on CHA2DS2- VASc scores and is recommended for anticoagulation therapy*.
✓ Patient is deemed by their physicians to be suitable for oral anticoagulation (OAC).
✓ Patient has an appropriate rationale to seek a non-pharmacologic alternative to OAC, taking into account the safety and effectiveness of the device compared to OAC.
✓ Patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
✓ Patient is able and willing to return for required follow-up visits and examinations.
* Medicare patients need to meet the CMS NCD 20.34.
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.