Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Recruiting now
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT06436924
- Run by
- Heart Rhythm Clinical and Research Solutions, LLC
- People needed
- 678
- Starts
- 2024-05-14
- Expected to finish
- 2026-03-30
- Last updated by the study team
- 2025-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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
Where it is running
- Grandview Medical Center — Birmingham, Alabama, United States (enrolling)
- Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
- The Medical Center of Aurora — Aurora, Colorado, United States (enrolling)
- Ascension St. Vincent — Jacksonville, Florida, United States (enrolling)
- Naples Community Hospital — Naples, Florida, United States (enrolling)
- Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
- Medical University of South Carolina — Columbia, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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