RecruitingAtrial Fibrillation
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
You may qualify if…
- ✓ 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 ≥ 8 LAAO device implant procedures, regardless of the device manufacturer
- ✓ 6. Willing and able to provide informed consent
You may not qualify if…
- ✕ 1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- ✕ 2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
- ✕ 3. 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's recruiting
Source: ClinicalTrials.gov · NCT06436924 · last updated 2025-10-30