NCT06436924Completed
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 569 (actual)
- First submitted
- 22 May 2024
- Start date
- 14 May 2024
- Primary completion date
- 19 Mar 2026
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Diseases
- Atrial fibrillation
- NCT number
- NCT06436924
What you commit to
- Study type: Observational
- Participants enrolled: 569
- From 14 May 2024 to the primary completion date, 19 Mar 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Medical Center of Aurora Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Grandview Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Ascension St. Vincent Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Naples Community Hospital Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| PIMA Heart and Vascular Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.