RecruitingNCT06436924

Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Enrollment

678 participants

Start Date

May 14, 2024

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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
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 ≥ 8 LAAO device implant procedures, regardless of the device manufacturer
Willing and able to provide informed consent

Exclusion Criteria3

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