Actively Recruiting
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Led by Heart Rhythm Clinical and Research Solutions, LLC · Updated on 2025-10-30
678
Participants Needed
7
Research Sites
97 weeks
Total Duration
On this page
Sponsors
H
Heart Rhythm Clinical and Research Solutions, LLC
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (at least 8 implant procedures by the physician in one day) within 2 calendar days prior to the planned procedure date
- Willing and able to provide informed consent
You will not qualify if you...
- 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 when the single implanting physician scheduled fewer than 8 LAAO device implant procedures within 2 calendar days prior to the planned procedure date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
Actively Recruiting
2
Pima Heart and Vascular
Tucson, Arizona, United States, 85704
Actively Recruiting
3
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Actively Recruiting
4
Ascension St. Vincent
Jacksonville, Florida, United States, 32204
Actively Recruiting
5
Naples Community Hospital
Naples, Florida, United States, 34102
Actively Recruiting
6
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
7
Medical University of South Carolina
Columbia, South Carolina, United States, 29204
Actively Recruiting
Research Team
J
Jennifer Moss
CONTACT
C
Carolyn Mills
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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