Evaluating the safety and effectiveness of high-volume left atrial appendage device implants

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

This study is testing whether having a doctor perform a lot of left atrial appendage device implants in one day is just as safe and effective as having them done less frequently, to help improve future procedures.

Quick facts

• Study type: Observational
• Enrollment: 678 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC (Academic / other)
• Locations: 7 sites (Birmingham, Alabama and 6 other locations)
• Trial ID: NCT06436924 on ClinicalTrials.gov

What this trial studies

This observational study assesses the real-world clinical experience of centers where a single physician performs eight or more left atrial appendage occlusion (LAAO) device implant procedures in one day. It aims to determine if high-volume procedures are as safe and effective as those performed at lower volumes by comparing outcomes to existing data from previous clinical trials. Additionally, the study will analyze the workflows of these high-volume implanters to identify factors that contribute to successful outcomes, potentially helping to optimize procedures in the future.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are clinically eligible for a LAAO device and scheduled for a high-volume implant procedure.

Not a fit: Patients currently enrolled in other investigational trials or those with contraindications to LAAO devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accessibility and efficiency of LAAO device implants for patients with atrial fibrillation.

How similar studies have performed: While previous studies have not differentiated between high and low volume cases, this approach is novel and aims to fill that gap in knowledge.

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

Where this trial is running

Birmingham, Alabama and 6 other locations

• Grandview Medical Center — Birmingham, Alabama, United States (Recruiting)
• Pima Heart and Vascular — Tucson, Arizona, United States (Recruiting)
• The Medical Center of Aurora — Aurora, Colorado, United States (Recruiting)
• Ascension St. Vincent — Jacksonville, Florida, United States (Recruiting)
• Naples Community Hospital — Naples, Florida, United States (Recruiting)
• Memorial Health University Medical Center — Savannah, Georgia, United States (Recruiting)
• Medical University of South Carolina — Columbia, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Saumil Oza, MD — St. Vincent's
• Study coordinator: Jennifer Moss

Conditions Atrial Fibrillation