Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

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.

Conditions

Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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.

Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Savannah

Memorial Health University Medical Center, Savannah, Georgia, United States, 31404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 6. Willing and able to provide informed consent
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Heart Rhythm Clinical and Research Solutions, LLC,

Saumil Oza, MD, PRINCIPAL_INVESTIGATOR, St. Vincent's

Study Record Dates

2025-12-30