NCT06436924 · Heart Rhythm Clinical and Research Solutions, LLC
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
What this study is about
SAFE HV is an observational, forward-looking, multi-center, non-randomly assigned 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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Birmingham, Alabama
- Tucson, Arizona
- Aurora, Colorado
- Jacksonville, Florida
- Naples, Florida
- Savannah, Georgia
- Columbia, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations