Clinical trial NCT06436924: Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
Official title: Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-05-31
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).

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 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.

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

Primary outcomes:
measure: Peri-procedural complications
timeFrame: Procedure through discharge, an average of 1-3 days
measure: Peri-device leakage
timeFrame: Date of implant up to 90 days
measure: Late onset complications
timeFrame: Discharge to 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Jacksonville
country: United States
facility: Ascension St. Vincent
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
Study officials:
affiliation: St. Vincent's
name: Saumil Oza, MD
role: PRINCIPAL_INVESTIGATOR
References: