SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.
18 years of age or older
Able and willing to participate in baseline and follow up evaluations for the full length of the study
Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled < 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date
Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Boston Scientific Corporation
Collaborator