Heart Rhythm Clinical and Research Solutions, LLC
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.
Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option. Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many r…
Inclusion Criteria: 1. 18 years of age or older 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care 5. Having their LAAO device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date \*high-volume - a calendar day in which the single implanting physician schedules…
The Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.