Thank you for reviewing the LAO Registry Monthly Case Scenario for February 2021. We will be discussing the Registry's Submission Population Inclusion Criteria, focusing on patients participating in a trial or study. Our patient, Mrs. Jackson, is admitted for an LAA Occlusion Procedure. The patient's past history includes persistent atrial fibrillation, hypertension, hemorrhagic stroke, labile INR levels. The patient was enrolled in the Option Trial and a Watchman FLX was implanted. Based on the documentation, a Watchman FLX was implanted during the procedure and the patient was part of the Option Trial. Our question is, will Mrs. Jackson's procedure be included in the registry, yes or no? Please take a moment to review the documentation and the question. The answer is number two, no. Based on the updated Submission Population Inclusion Criteria document, patients enrolled in the Option, Champion, AF, and ASAP2 trial will be excluded from the registry. Additional information to share. Patients who have a Watchman FLX implanted and are not participating in the Option Trial will be included in the registry as long as the procedure was on or after July 21, 2020, which is the date the device was FDA approved. Patients that are part of the Amulet and Wavecrest Trials who are randomized to the Watchman arm of the study and have a Watchman device implanted will be included in the registry. The patients who are randomized and have an Amulet or Wavecrest device implanted will not be included in the registry as these devices do not have FDA approval. Lariat procedures that are part of the AMAZE trial will not be included in the registry. Please refer to the updated Registry Submission Population Inclusion Criteria document located under the Resources tab and Documents. The document is found under User Guide Documents. Thank you for viewing the LEAO Registries Case Scenario for February 2021.

LAO Registry

Mrs. Jackson

LAA Occlusion Procedure

Option Trial

Registry Submission Population Inclusion Criteria