Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
1 other identifier
observational
678
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2024
CompletedFirst Submitted
Initial submission to the registry
May 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedOctober 30, 2025
October 1, 2025
1.6 years
May 22, 2024
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Peri-procedural complications
Incidence of peri-procedural complications summarized descriptively and compared to historical data
Procedure through discharge, an average of 1-3 days
Peri-device leakage
Assessed by successful closure of the left atrial appendage defined by peri-device leakage of \<5mm. This will be identified at the post implant imaging.
Date of implant up to 90 days
Late onset complications
Incidence of post procedure complications summarized descriptively and compared to historical data.
Discharge to 30 days.
Study Arms (1)
Subjects undergoing LAAO device implant
Watchman LAAO device implant
Interventions
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.
Eligibility Criteria
The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Pima Heart and Vascular
Tucson, Arizona, 85704, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Ascension St. Vincent
Jacksonville, Florida, 32204, United States
Naples Community Hospital
Naples, Florida, 34102, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Medical University of South Carolina
Columbia, South Carolina, 29204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saumil Oza, MD
St. Vincent's
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
May 31, 2024
Study Start
May 14, 2024
Primary Completion
December 30, 2025
Study Completion
March 30, 2026
Last Updated
October 30, 2025
Record last verified: 2025-10