Observational Study of High-Volume Watchman Device Implants
This study, called SAFE HV, is looking at the safety and effectiveness of the Watchman FLX™ or Watchman FLX Pro™ device when many implants are done by one doctor on the same day. The Watchman device is placed in the left atrial appendage (a small pouch in the heart) to prevent blood clots from forming and causing a stroke in people with atrial fibrillation (an irregular heartbeat). Researchers want to see if these high-volume procedures are as safe and effective as those done at lower volumes. You could join if you are 18 or older, are getting a Watchman FLX™ or Watchman FLX Pro™ device as part of your care, and are willing to participate in follow-up. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study involving 678 participants. It is not randomized, meaning participants are not assigned to different treatment groups by chance.
- What's involved
- You would participate in baseline and follow-up evaluations for the full length of the study. This includes monitoring for complications from the procedure through discharge (1-3 days), for peri-device leakage up to 90 days, and for late complications up to 30 days after discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for peri-procedural complications through discharge (1-3 days), for peri-device leakage up to 90 days after implant, and for late onset complications from discharge to 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
At a glance
Conditions
NCT06436924
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ascension St. Vincent
Jacksonville, Floridano site contact published
Grandview Medical Center
Birmingham, Alabamano site contact published
Medical University of South Carolina
Columbia, South Carolinano site contact published
Memorial Health University Medical Center
Savannah, Georgiano site contact published
Naples Community Hospital
Naples, Floridano site contact published
Pima Heart and Vascular
Tucson, Arizonano site contact published
The Medical Center of Aurora
Aurora, Coloradono site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Saumil Oza, MD · PRINCIPAL_INVESTIGATOR · St. Vincent's
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Peri-procedural complicationsProcedure through discharge, an average of 1-3 days
Incidence of peri-procedural complications summarized descriptively and compared to historical data
- Peri-device leakageDate of implant up to 90 days
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.
- Late onset complicationsDischarge to 30 days.
Incidence of post procedure complications summarized descriptively and compared to historical data.