Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436924
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-22
Brief Title:
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Sponsor:
Heart Rhythm Clinical and Research Solutions LLC
Organization:
Heart Rhythm Clinical and Research Solutions LLC
Study Overview
Official Title:
Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day SAFE HV
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 200000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None