Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18 years of age or older 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care 5. 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 6. Willing and able to provide willing to sign a consent form Who Should NOT Join This Trial: 1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure 3. 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 18 years of age or older 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care 5. 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 6. Willing and able to provide informed consent Exclusion Criteria: 1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure 3. 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

Treatments Being Tested

DEVICE

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