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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35243
- Grandview Medical Center
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Arizona
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Tucson, Arizona, United States, 85704
- PIMA Heart and Vascular
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Colorado
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Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
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Florida
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Jacksonville, Florida, United States, 32204
- Ascension St. Vincent
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Naples, Florida, United States, 34102
- Naples Community Hospital
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Georgia
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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South Carolina
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Columbia, South Carolina, United States, 29204
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the study
- Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
- Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
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
- Willing and able to provide informed consent
Exclusion Criteria:
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Subjects undergoing LAAO device implant
Watchman LAAO device implant
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Peri-procedural complications
Time Frame: Procedure through discharge, an average of 1-3 days
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Incidence of peri-procedural complications summarized descriptively and compared to historical data
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Procedure through discharge, an average of 1-3 days
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Peri-device leakage
Time Frame: Date of implant up to 90 days
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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.
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Date of implant up to 90 days
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Late onset complications
Time Frame: Discharge to 30 days.
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Incidence of post procedure complications summarized descriptively and compared to historical data.
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Discharge to 30 days.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Saumil Oza, MD, St. Vincent's
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAFE HV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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