Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Recruiting · NCT06436924 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Left Atrial Appendage Device Implant
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
7 locations listed across 6 US states.
- Grandview Medical Center - Birmingham, Alabama, United States
- Pima Heart and Vascular - Tucson, Arizona, United States
- The Medical Center of Aurora - Aurora, Colorado, United States
- Ascension St. Vincent - Jacksonville, Florida, United States
- Naples Community Hospital - Naples, Florida, United States
- Memorial Health University Medical Center - Savannah, Georgia, United States
- Medical University of South Carolina - Columbia, South Carolina, United States