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

Launched by HEART RHYTHM CLINICAL AND RESEARCH SOLUTIONS, LLC · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called SAFE HV, is studying the safety and effectiveness of a specific type of heart procedure known as left atrial appendage occlusion (LAAO) for patients with a heart rhythm problem called atrial fibrillation. The trial looks at how well experienced doctors can perform multiple LAAO procedures in one day, specifically when they do eight or more procedures in a single day. This study is being conducted at various centers, and researchers want to learn more about the real-world experiences of patients undergoing this treatment.

To participate in the trial, you need to be at least 18 years old and have been deemed suitable for the LAAO procedure by your doctor. You should also be scheduled to receive a Watchman FLX™ or Watchman FLX Pro™ device on a day when the doctor is performing eight or more procedures. If you qualify, you can expect to take part in both a baseline evaluation and follow-up assessments throughout the study. This trial is currently recruiting participants, and it's important that you can provide informed consent, meaning you understand what the study involves and agree to take part.

Gender

ALL

Eligibility criteria

• 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