NCT06436924

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 678 (estimated)
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option. Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. While there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the PINNACLE FLX clinical trial and the SURPASS analysis to ensure that safety and efficacy outcomes are comparable. Additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of Watchman FLX™ implants in a single day. In the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-14
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2024-05-31
• Last updated: 2025-10-30

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study