SIMPLAAFY Clinical Trial (SIMPLAAFY)

Overview

About this study

The purpose of this study 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

  • Subject is of legal age to participate in the study per the laws of their respective geography.
  • Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
  • Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
  • The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
  • The subject is able and willing to return for required follow-up visits and examinations.

Key Exclusion Criteria:

  • Subject's device implant procedure was aborted.
  • Subject has a device margin residual leak > 0mm at time of implant.
  • Occurrence of periprocedural complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure.
  • Subject has a contraindication to one of the three protocol defined drug regimens
  • Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/12/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ammar Killu, M.B.B.S.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available