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Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
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.
Official title: Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
678
Start Date
2024-05-14
Completion Date
2026-03-30
Last Updated
2025-10-30
Healthy Volunteers
No
Conditions
Interventions
Left Atrial Appendage Device Implant
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.
Locations (7)
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