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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436924
• Other study ID #: SAFE HV
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Heart Rhythm Clinical and Research Solutions, LLC
• Contact: Lynn Landborg
• Phone: 763-381-9135
• Email: safe[@]hrcrs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 678
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Health University Medical Center	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Heart Rhythm Clinical and Research Solutions, LLC	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-procedural complications	Incidence of peri-procedural complications summarized descriptively and compared to historical data	Procedure through discharge, an average of 1-3 days
Primary	Peri-device leakage	Assessed by successful closure of the left atrial appendage defined by peri-device leakage of <5mm. This will be identified at the post implant imaging.	Date of implant up to 90 days
Primary	Late onset complications	Incidence of post procedure complications summarized descriptively and compared to historical data.	Discharge to 30 days.