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Atrial Fibrillation / Stroke / Bleeding SIMPLAAFY

Status: Open to Enrollment
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Study Details

View study details on www.clinicaltrials.gov.

Locations

  • Palo Alto
  • Mountain View
  • Burlingame

Clinical Trial FAQs

Information for patients and study volunteers, including frequently asked questions.

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):

  1. Aspirin only
  2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
  3. DAPT
Chad Rammohan
Chad Rammohan
Principal investigator
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