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
The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).
Case-only
Prospective
Left Atrial Appendage Device Implant
DeviceThe Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.
Peri-procedural complications
Incidence of peri-procedural complications summarized descriptively and compared to historical data
Peri-device leakage
Assessed by successful closure of the left atrial appendage defined by peri-device leakage of \<5mm. This will be identified at the post implant imaging.
Late onset complications
Incidence of post procedure complications summarized descriptively and compared to historical data.
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Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Boston Scientific Corporation
Collaborator
